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July 2024

How does extreme heat affect medicines and those taking them?

July 25,2024 London: The world just experienced the hottest day on record and prolonged heat waves have become more common due to climate change, conditions that can alter medications and their effects on patients taking them. Here is what you need to know about medicines in hot weather: Medications for common conditions can increase patients’ sensitivity to heat by impairing the body’s response to high temperatures, including the ability to sweat and the rate of blood flow. Heat waves also increase the risk of deterioration for nearly all medications, whether capsules, sprays, tablets, syrups, or some other form, if they are not kept within a certain temperature range. The heat-related effects of medications can vary based on individual health status, dosage and environmental conditions. Patients should consult their physicians about potentially adjusting doses or scheduling in hot weather, and they should keep cool by staying hydrated, carrying fans, and seeking shade or air conditioning, experts say. Blood pressure and heart failure medications: Angiotensin converting enzyme (ACE) inhibitors suppress thirst, making it harder to know when to drink more water and increasing the risk of dehydration. Calcium channel blockers can cause mineral imbalances, making it harder for the body to regulate its temperature, while beta blockers can make it harder to sweat and keep the body cool. Diuretics, or water pills, can also cause dehydration and mineral imbalances. Allergy medications: Some over-the-counter antihistamines reduce sweating and can impair temperature regulation. Psychiatric medications: Certain antipsychotic medications limit patients’ ability to sweat. Some antidepressants have the opposite effect, increasing sweating and repressing thirst. Stimulants such as amphetamines and other drugs used to treat attention deficit hyperactivity disorder may interact with the central nervous system to raise body temperature. Thyroid medications: Thyroid hormone pills also can raise body temperature, impair temperature regulation and cause excessive sweating. Extreme heat (and extreme cold) can significantly alter the effectiveness of prescription and over-the-counter drugs. Some medications can tolerate temperatures up to 86 degrees Fahrenheit (30 Celsius), but in general they should be stored at 59-77 F (15-77 C) in a cool, dry place, away from sunlight. Temperature storage guidelines for specific drugs can be found on manufacturers’ websites. It’s hard to predict the extent to which a medication will degrade in extreme temperatures because each drug is different, said Amy Bachyrycz, a pharmacy faculty member at the University of New Mexico in Albuquerque. In general, medicines should not be left in hot cars or for hours in hot mail boxes if they are mail-ordered medications. A spokesperson for CVS Health’s Caremark pharmacy benefits unit said the company’s electronic shipping system takes weather data into account to determine appropriate packaging materials for each shipment. An Amazon.com Pharmacy spokesperson said the company employs strict storage and delivery safety measures to protect medications from extreme temperatures throughout the shipping process. Source: Healthworld

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ICMR releases 32 new standard treatment workflows for common and serious diseases

July 25,2024 New Delhi: The Indian Council of Medical Research (ICMR), in collaboration with the National Health Authority (NHA) and WHO India, has released 32 new Standard Treatment Workflows (STWs) for common and serious diseases. The new STWs cover five specialties, including cardiothoracic vascular surgery, paediatric cardiology, interventional radiology, neurosurgery, and orthopaedics, adding to the 125 STWs previously released across 23 specialties in 2019 and 2022. During the Volume-IV launch of Standard Treatment Workflows at ICMR, Department of Health Research (DHR) Secretary and ICMR Director General Rajiv Bahl emphasised the significance of these protocols and said that these standard protocols save lives and improve the quality of care. “By incorporating these workflows into medical education from the beginning, we strengthen the foundation of our healthcare professionals . We also aim to disseminate these workflows to healthcare insurance companies, healthcare centres, central health systems, and medical professional bodies,” Rajiv Bahl said speaking on occasion. National Health Authority (NHA) Chief Executive Officer Deepti Gaur Mukerjee shared her positive outlook on the collaboration and highlighted future plans. “Our joint initiative with ICMR for the development of these workflows has been a fruitful endeavour. We’ve put considerable effort into broadening the specialties encompassed by the STWs. Looking forward, specialties such as burn management, plastic surgeries, and polytrauma will take centre stage in our future efforts. Our aim is to persistently enhance patient care by covering a more diverse range of medical fields through our STWs,” Deepti Gaur Mukerjee said. Endorsing the STWs, Member NITI Aayog Vinod Kumar Paul said, “These vital tools have been the guiding light since inception, shaping a resilient future. These evidence-based and trusted workflows ensure that patients receive the right treatment, while standardisation helps healthcare professionals follow guidelines effectively.” “Transformative and reliable, they guarantee accurate patient care. Standardisation empowers healthcare professionals to easily adhere to guidelines, ensuring effective treatment protocols for all. Let’s not just know but apply these STWs, instilling pride in India’s healthcare system,” VK Paul said. Senior Deputy Director General and Head Delivery Research at ICMR Ashoo Grover highlighted the impact of these STWs and said that the dissemination of the STWs has been remarkable, both nationally and internationally. “Our collaboration with National Institute of Health & Family Welfare (NIHFW) has resulted in the publication of three manuscripts in PubMed-indexed journals. The development of these workflows is a challenging process, aiming to streamline healthcare in India. By incorporating STWs into practice, physicians can provide targeted treatment, while the public gains confidence in the healthcare system,” he said. The ICMR introduces evidence-based STWs to enhance medical care consistency in India. These guidelines, created by national experts, promote optimal treatment practices, rational drug use, and efficient healthcare services. Each concise one-page document outlines key actions for physicians, ensuring uniform healthcare standards in India’s public healthcare system. The Indian Council of Medical Research (ICMR) remains committed to advancing standardised and evidence-based care through the development and implementation of the Standard Treatment Workflows (STWs). These workflows not only empower healthcare professionals but also ensure the provision of high-quality care to patients across the country. (ANI) Source: Healthworld

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ETPharma to host second edition of Next-Gen LabCon themed, ‘Future-Ready Labs: Analog to Digital’

July 25,2024 Hyderabad: ETPharma will be hosting the second edition of the Next-Gen Lab-Con on July 26, 2024, at Le Meridien, Hyderabad. The conference aims to bring together industrial leaders to focus on the pharmaceutical landscape, which is rapidly evolving and to discuss what will be the future generation of pharma labs and their regulatory obligations. The second edition of ETPharma’s Next-Gen LabCon, themed ‘Future-Ready Labs: Analog to Digital’ will focus on the seamless progression of a product life cycle, heightened competition and building next-gen, future-ready pharma labs, which is crucial to fulfilling the demand for innovative therapies, enhancing approval rates, minimising expenses, accelerating time-to-market, and adhering to regulatory obligations. The conclave will commence with a welcome address by Vikas Dandekar, Editor, ETPharma, followed by the Chief Guest’s address on the topic ‘Navigating the future of Pharmaceutical Exports: Quality Imperatives and Global Compliance’ by Raja Bhanu, Director General, Pharmexcil. The Chief Guest’s address will be followed by a panel discussion on ‘Indian Laboratories – what does it take, to take it to a global scale?’. The panellists for the session will be Annaswamy Vaidheesh, Executive Chairperson, Suven Pharma; Dr KVS Ram Rao, CEO & Joint Managing Director, Granules India, Akhil Ravi, Chief Executive Officer, Aurigene Pharmaceutical Services, and Dr Sauri Gudlavalleti, Chief Operating Officer, Sai Lifesciences. The session will be moderated by Vikas Dandekar, Editor, ETPharma. The session on ‘Indian Laboratories – what does it take, to take it to a global scale? will be followed by a panel discussion on ‘Role of Sensors, AI, ML, RPA in Enhancing R&D Experimentation’. The panellists for the session will be Dr Mandar Ghatnekar, Global Head of IT & Digital Transformation , Biocon Biologics; Chitti Babu, Chief Information Officer (CIO), Aurobindo Pharma; Rithesh Phalaksha, Director – Leading Digital Innovation, Novartis; and Dr Sujay Rajhans, President, Head R&D, JB Pharma. The session will be moderated by Chakravarthi AVPS, Chairman, Federation of Pharma Entrepreneurs – Telangana & Andhra Pradesh, FOPE South. The panel discussion on ‘Role of Sensors, AI, ML, RPA in Enhancing R&D Experimentation’ will be followed by a case study on Gen AI by Tushar Zade, CDO & CIO, Aurigene Pharmaceuticals Services Ltd. The Gen AI case study will be followed by a panel discussion on ‘Ask the Experts- Upscaling to Electronic Batch Records: Lessons from a Pharmaceutical Manufacturer’. The panellists for the discussion include Dr Pavan Bhat, Executive Director, Natco Pharma, Sandeep Raktate, President – India & Ireland Operations, Amneal Pharmaceuticals. The session will be moderated by Vikas Dandekar, Editor, ETPharma. The ‘Ask the Experts- Upscaling to Electronic Batch Records: Lessons from a Pharmaceutical Manufacturer’ session will be followed by another panel discussion on ‘Implementing Green Chemistry Principles in CDMO Operations: A Sustainable Digital Transformation Journey’. The panellists for the dialogue include Dr Vijayavitthal T Mathad, Chief Operating Officer, CRAMSN Research Park, Dr Damodharan Muniyandi, Chief Quality Officer, Global Quality & Regulatory Affairs, Sai Life Sciences Ltd; Dr Rakeshwar Bandichhor, Vice President and Head of Chemistry, API Process R&D, Dr Reddy’s Laboratories. The moderator for the session will be Ivy Louis, Board Member, Parenteral Drug Association (PDA Inc.); Director-Vienni Training & Consulting LLP. The conference will conclude with the closing remarks by Prabhat Prakash, Senior Digital Content Producer, ETPharma. Source: Pharma

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Humanity suffering from ‘extreme heat epidemic,’ UN chief warns

July 26,2024 London: Humanity is suffering from an “extreme heat epidemic,” UN Secretary-General Antonio Guterres warned Thursday, calling for action to limit the impacts of heat waves intensified by climate change. “Billions of people are facing an extreme heat epidemic — wilting under increasingly deadly heat waves, with temperatures topping 50 degrees Celsius around the world,” he said. “That’s 122 degrees Fahrenheit. And halfway to boiling.” According to the European Copernicus network , July 21, 22 and 23 were the three hottest days ever recorded worldwide, with July 22 holding the absolute record of 17.16 degrees Celsius (62.9 degrees Fahrenheit). Guterres repeated his call for humanity to fight its “addiction” to fossil fuels. “Today, our focus is on the impact of extreme heat . But let’s not forget that there are many other devastating symptoms of the climate crisis: ever-more fierce hurricanes. Floods. Droughts. Wildfires. Rising sea levels. And the list goes on,” he said. “To tackle all these symptoms, we need to fight the disease. And the disease is the madness of incinerating our only home. The disease is the addiction to fossil fuels. The disease is climate inaction,” he stressed, calling in particular on G20 countries to take action. While 2023 was the hottest year on record, and 2024 could set a new record, temperatures well above 40C (104F) are increasingly common. In the space of a year, the 50C threshold has even been exceeded in at least 10 places, from Death Valley in the United States (53.9C on July 7) to Agadir in Morocco, and also in China and India. The intense heat, often less visible than other devastating impacts of climate change such as storms or floods, is nonetheless more deadly. This “silent killer” is responsible for around 489,000 deaths per year between 2000 and 2019, compared with 16,000 deaths per year from cyclones, according to the UN’s “Call to Action” document published on Thursday. Extremely high temperatures also have an economic impact, with the UN estimating economic losses from heat stress at work will reach $2.4 trillion in 2030. According to a report by the International Labor Organisation published on Thursday, more than 70 percent of workers were exposed to excessive heat in 2020, 8.8 percent more than in 2000. “The good news is that we can save lives and we can limit its impact,” Guterres said Thursday. The UN has called for the world community to first act to protect “the most vulnerable” — including young children, the elderly and also humanity’s poorest. In this context, early warning systems should include extreme heat, warning populations of the arrival of heat waves and informing them of the precautions to take, the document says. The call to action also recommends an “increase (to) equitable access to and scale up (of) low-carbon cooling.” This would involve investing in passive cooling systems — which include climate-sensitive urban design measures, reflective surfaces and natural cooling systems — and the phase-out of climate-warming gases that are used in many cooling systems. Source: Healthworld

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World Health Organisation appeals to prevent the heartbreak of drowning, save lives

July 26,2024 New Delhi: The WHO Regional Director for Southeast Asia, Saima Wazed, appealed to everyone on Thursday, July 25, to save lives and prevent the heartbreak of drowning on World Drowning Prevention Day. She said, “We join the global community in observing World Drowning Prevention Day, dedicated to raising awareness and accelerating action on global drowning prevention. The World Health Assembly Resolution WHA76.18, passed in 2023, underscores the urgent need for coordinated multi-sectoral action to combat this leading cause of injury-related death and disability worldwide.” Highlighting this year’s theme, “Anyone can drown, no one should,” she said, “This year, under the overarching theme “Anyone can drown, no one should,” the World Health Organisation has chosen the slogan “Seconds can save a life.” This highlights the dual nature of drowning: it can occur in a matter of seconds yet taking a brief moment to act–whether by wearing a lifejacket, keeping watch over children while they are near water, checking the weather forecast before boating, or choosing safety over distraction–can prevent a tragedy.”. “Drowning is a sudden and silent killer, often catching victims and those around them unaware until it is too late. A few seconds may not be enough time to respond. The power is in prevention,” she added. Globally, an estimated 236,000 lives are lost to drowning every year–an average of 650 every day, or 26 every hour. This silent epidemic of preventable deaths excludes drownings related to flood disasters and water transport incidents, thus underreporting the true magnitude of the issue. She further added, “In our Southeast Asia Region, the consequences of drowning are particularly devastating. In 2019 alone, drowning claimed 70,034 lives, making it the second-highest contributor to drowning deaths worldwide after the Western Pacific Region. Most of these tragedies occur within proximity of the home, primarily due to a lack of supervision, exposure to hazardous water bodies, a lack of awareness and education, as well as poverty.”. WHO is finalising the Global Status Report on Drowning, set to be launched by the end of 2024. This report will provide updated information on the global burden of drowning and will generate key recommendations for impactful actions at global, regional, and national levels. WHO has outlined evidence-based, cost-effective, and scalable measures to prevent drowning and provided detailed guidance for their implementation. While the application of these measures will vary by context, the global drowning prevention community must remain vigilant and coherent in its efforts. “We all have a role to play in preventing drowning. Whether by raising awareness, promoting knowledge of effective solutions, collaborating on prevention plans and policies with local or national governments, volunteering with relevant organisations, or ensuring personal and family safety around water, each of us can make a difference,” she added. (ANI) Source: Healthworld

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37 cases of Chandipura virus detected in Gujarat, says State Health Minister

July 26,2024 New Delhi: Gujarat Health Minister Rushikesh Patel said on Friday that 37 cases of Chandipura virus have been detected across the state and the state government has taken a lot of initiatives to control the disease. He also said that about 133 cases of the Chandipura virus have been registered so far in the state. Speaking on the rising case of Chandipura virus at a press conference here, Patel said, “About 133 cases have been registered so far. Of these 37 cases are confirmed for Chandipura and the remaining cases can’t be spoken of as confirmed, as far as the symptoms are concerned. We can’t call them Acute Viral Syndrome for certain”. “Acute Viral Syndrome occurs every year but the number has gone up this year. State Government has taken a lot of initiatives for this…,” Patel added. Earlier in the month, Gujarat Chief Minister Bhupendra Patel reviewed the situation in the state amid the Chandipura virus and took stock of the measures taken to control the epidemic. Chandipura Virus (CHPV) is a member of Rhabdoviridae family known to cause sporadic cases and outbreaks in western, central, and southern parts of the Country, especially during the monsoon season. It is transmitted by vectors such as sand flies and ticks. It is to be noted that vector control, hygiene, and awareness are the only measures available against the disease. The disease affects mostly children under 15 years of age and can be present with a febrile illness that may in some cases result in death. Although there is no specific treatment available for CHPV and management is symptomatic, timely referral of suspected AES cases to designated facilities can improve outcomes. Since early June 2024, cases of Acute Encephalitis Syndrome (AES) have been reported in children under 15 years of age in Gujarat. (ANI) Source: Healthworld

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Over 1800 disease outbreaks reported across country last year: Govt

July 26,2024 New Delhi: A total of 1,862 disease outbreaks were reported to the Integrated Disease Surveillance Programme last year, with the highest number being reported from Kerala, the Lok Sabha was informed on Friday. Kerala reported 253 outbreaks followed by Karnataka at 223, Maharashtra at 208 and Madhya Pradesh at 140. Responding to a question, Minister of State for Health Anupriya Patel said prevention of and preparedness against pandemics is a shared global responsibility. In order to better prepare against future pandemics or public health emergencies in the country, the Union Ministry of Health provides requisite support to states and UTs to enhance their capabilities, Patel said in a written reply. To enhance disease surveillance activities, the ministry has strengthened the Integrated Disease Surveillance Programme (IDSP), which allows for a decentralized system of response through trained multi-disciplinary Rapid Response Team to institute requisite public health control and containment measures. The IDSP, under Integrated Health Information Platform (IHIP), has also been strengthened to use advanced data modelling and data analytical tools, contains real-time data reporting, accessible at all levels, she said. The Ministry of Health and Family Welfare launched the portal of Integrated Health Information Platform on April 5, 2021. It is designed to capture case-based data of more than 33 plus health conditions along with special surveillance of ILI/SARI, COVID-19 and Monkey Pox, she said. It provides a single operating platform of public health surveillance of the individuals at district, state and national levels. At present, all the 36 states and UTs have completely migrated to IHIP portal. In terms of laboratory strengthening, under IDSP, states have strengthened laboratories at district and state levels. Further, the Indian Council of Medical Research (ICMR) has established a network of more than 150 Virus Research and Diagnostic Laboratories for strengthening of nation-wide network of laboratories for timely laboratory based diagnosis of pathogens. In addition besides apex laboratory at National Institute of Virology (NIV), Pune and four regional NIVs are being established in Jammu, Jabalpur, Dibrugarh and Bengaluru. The ICMR has developed two mobile BSL-3 laboratories to provide essential on-site diagnostic services during outbreaks, especially in remote areas. Further, a National Institute for One Health (NIOH) is being established at Nagpur by ICMR to undertake integrated and holistic research and development across human, animal, plant, and environmental health sectors. The IDSP is mandated with surveillance and response to outbreak prone communicable diseases. Any case of outbreak prone disease in the country is investigated as a part of outbreak investigation by rapid response teams at district, state and central level as per the need, Patel said. These RRTs recommend necessary precautions in order to prevent the spread of diseases. IDSP also performs media scanning and verification of print and electronic media to strengthen the event-based surveillance. Source: Healthworld

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“Two more people test negative for Nipah,” says Kerala Health Minister Veena George

July 27,2024 Kozhikode: Kerala Health Minister Veena George announced that the test results of two more people for the Nipah virus have come out negative, bringing the total number of negative samples to 68. Four new admissions have been reported, with a total of five people currently undergoing treatment. There are 472 individuals on the contact list, including 220 in the high-risk category. So far, 807 people have received mental health services. Minister Veena George participated online in the Nipah review meeting held at Malappuram Collectorate. The Minister said that all individuals on the contact list must strictly follow the isolation guidelines for 21 days. Discharged patients must also adhere to isolation guidelines. Strict action will be taken against those who do not comply, the minister said. The minister also requested that people wear masks and maintain social distance. Notably, the Centre has advised immediate public health measures to be taken by the state government, such as active case searches in the family of the confirmed case, the neighbourhood, and areas with similar topography. The Centre has also advised active contact tracing (for any contacts) and strict quarantine of the contacts in the case, isolation of any suspects, and collection and transportation of samples for lab testing. It is important to note that outbreaks of Nipah Virus Disease (NiVD) have been reported in Kerala in the past, with the most recent one occurring in 2023 in the Kozhikode district. Source: Healthworld

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NTA declares final NEET-UG results, number of toppers down to 17 from 61

July 27,2024 New Delhi: The National Testing Agency (NTA) Friday declared the final results of controversy-ridden NEET-UG entrance exam, declaring that 17 candidates have shared the top rank, down from 61 in the revised results, while thousands of others have seen their marks and rankings change significantly. The number of qualifying candidates and the cut-off has also seen a marginal dip. The “re-revised” results have been released three days after the Supreme Court rejected multiple petitions demanding a NEET-UG 2024 retest because of alleged paper leaks and other malpractices. The top court had, however, asked the NTA to revise the merit list in light of a controversial physics question which had two possible answers and the correct option was suggested by a three-member expert panel set up by the SC. It led to a complete reworking of NEET ranks and scores for all 2.3 million students. The scores of at least 4,20,000 students, including 44 of the 61 who achieved perfect 720, decreased by five points with the court invalidating the disputed marks they got for the Physics question. However, the exact impact on their rankings is not immediately clear. The exams was held on May 5 and the results were announced on June 4. Doubts about the sanctity of the exam arose when a total of 67 students scored a perfect 720, unprecedented in the NTA’s history. The number of candidates sharing the top rank came down to 61 after the NTA announced the revised results on July 1 after withdrawing grace marks awarded to six candidates to make up for loss of time some centres. On Friday, the NTA declared the “re-revised result” Along with a decrease in the number of toppers, the qualifying cutoffs and number of qualified candidates have also decreased in the the “re-revised” results of the National Eligibility-cum-Entrance Test-Undergraduate (NEET-UG). Seventeen candidates have retained the perfect 720 marks and were declared the toppers, followed by six who scored 716, and 77 with 715 marks, which forms the cohort of top 100 candidates. Forty-four out of the 67 candidates who were earlier declared toppers, when the results were originally announced on June 4, had scored full marks because of the marks awarded for that particular physics question. The percentage of female toppers increased in the revised results from 16 per cent to 23 per cent as there are four candidates in the top 17. The percentage of female among top 100 is 22 per cent. There are four candidates from Rajasthan, three from Maharashtra, two each from Delhi and Uttar Pradesh who are among the toppers. The other six are from Kerala, Chandigarh, Tamil Nadu, Punjab, Bihar and West Bengal. The total number of qualified candidates stands at 13,15,853, down by 415 candidates. There are 15 states/Union Territories which registered an increase in the total number of qualified candidates. These include Goa, Gujarat, Kerala, Uttarakhand, and West Bengal, among others. Even though the number of qualifiers decreased marginally, with over 1.65 lakh candidates, UP has the highest numbers, followed by Maharashtra (1.42 lakh) and Rajasthan (1.21 lakh). The other two states with over 85,000 qualifiers are Karnataka (88,887) and Kerala (86,713). The revision of the results also brought down the qualifying cutoffs – for the unreserved and economically weaker section the new cutoff range is 720-162, down from 164, while for the OBC, SC, ST it is 161-127. Category-wise the number of qualifiers decreased for unreserved, EWS, and OBC, while it increased for SC and ST. In a major setback to unsuccessful aspirants of NEET-UG 2024, the Supreme Court on Tuesday dismissed the pleas seeking cancellation and re-test of the controversy-ridden exam, holding that there was no evidence on record to conclude that it was “vitiated” on account of “systemic breach” of its sanctity. The verdict came as a shot in the arm for the embattled NDA government and the National Testing Agency (NTA), which were facing strong criticism and protests, on streets and in Parliament, over alleged large-scale malpractices like question paper leak, fraud and impersonation in the prestigious test held on May 5. The CBI is probing alleged irregularities in NEET-UG 2024 and has lodged six FIRs. The NEET-UG is conducted by the National Testing Agency for admissions to MBBS, BDS, AYUSH and other related courses in government and private institutions. Source: Healthworld

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Sun Pharma gets US FDA nod for its specialty drug against baldness

July 26,2024 New Delhi: Sun Pharma on Friday announced that the USFDA approved Leqselvi (deuruxolitinib) 8 mg tablets for the treatment of adults with severe alopecia areata (patchy baldness). The US regulator approval is a significant milestone for Sun Pharma which paid $576 million (Rs 4600 crore) in January 2023 to acquire Concert Pharmaceuticals to gain access to deuruxolitinib, portrayed as a “potential best-in-class” therapy. Shares of Sun Pharma rose 2.58 per cent and were trading at Rs 1708.20 at 11.10 am, the benchmark Sensex gained 0.84 per cent to 80,710.90 points. Deuruxolitinib, a twice- daily oral selective inhibitor of Janus Kinases (JAK) JAK1 and JAK2, is used for treatment of adults with moderate to severe alopecia areata,an autoimmune disease in which the immune system attacks hair follicles, resulting in partial or complete baldness. The disease affects up to 2.5 per cent of the US population. There are currently limited treatment options available for alopecia areata. Sun Pharma will have a five-year marketing exclusivity for the product. Abhay Gandhi, CEO, North America Business, Sun Pharma in May told ET that preparations were in full swing to commercialise the drug. Deuruxolitinib may be a huge boost to Sun Pharma’s global specialty business that crossed the $1 billion sales milestone in FY24. Jefferies’ forecasts that Deuruxolitinib can achieve sales of $765 million in the US and European markets by 2031, the research report also estimated pre-tax net present value is Rs 64 per share from the opportunity. Global specialty sales that contributed about 18 per cent of Sun Pharma revenue grew 19 per cent YoY to $ 1.04 billion in FY24. “Leqselvi offers a new and effective solution that will significantly enhance options for long-suffering patients battling severe alopecia areata and their physicians,” said Gandhi. “Our fast-growing dermatology business is excited to add this novel treatment to its portfolio,” he added. The approval is based on data from two multicenter, randomised, double-blind, placebo-controlled Phase 3 clinical trials THRIVE-AA1 and THRIVE-AA2, which enrolled a total of 1,220 patients with alopecia areata who had at least 50 per cent scalp hair loss as measured by Severity of Alopecia Tool (SALT) for more than six months. Data were also collected from two open-label, long-term extension trials in which patients were eligible to enroll upon completion of the 24-week trials. At study baseline, the average patient had only 13 per cent of their scalp hair coverage. “In the trials, at 24 weeks, the primary endpoint was met, with more than 30 per cent of patients taking Leqselvi (deuruxolitinib) experiencing 80 per cent or more scalp hair coverage (SALT ≤20),” the company said. “The number of patients taking LEQSELVI and achieving a SALT score of ≤20 showed a consistent upward trend with no plateau through 24 weeks. Additionally, up to 25 per cent of patients had almost all of their scalp hair back at 24 weeks,” it added. Source: Pharma

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