July 2024

July 26,2024 London: The European Union’s drugs regulator on Friday rejected Eisai and Biogen’s breakthrough treatment for early Alzheimer’s disease, in a blow to the drugmakers as take-up in the U.S. has been slower than expected. The agency’s Committee for Medicinal Products for Human Use had recommended not granting an authorization as the observed benefits did not counterbalance the risk of serious side events, especially brain swelling and bleeding or microhemorrhages. The recommendation has to be formally backed by the European Commission, which usually follows the regulator’s decision automatically. A March 21 hearing of the committee to discuss the drug was delayed due to structural changes within the agency, Eisai had said. The drug has been under review in the region since January 2023 and gained traditional approval in the U.S. last year. A treatment for Alzheimer’s disease has eluded drugmakers for decades. Another Eisai-Biogen drug called Aduhelm failed to take off in the U.S. after questions over its approval and data, and was never approved in Europe. In Europe, seven million people are living with the brain-wasting disease, and that figure is expected to double by 2050, according to Alzheimer’s Europe, a non-profit organization. The drug, lecanemab, is sold as Leqembi in the U.S. and was set to be Europe’s first drug to treat the neurodegenerative condition rather than its symptoms. Leqembi’s U.S. launch has so far been lackluster, with bottlenecks due to its requirements such as additional diagnostic tests, twice-monthly infusions and regular brain scans. The U.S. Food and Drug Administration had on July 2 approved Eli Lilly’s Alzheimer’s drug Kisunla. Unlike Leqembi, Kinsula requires finite dosing, which allows patients to stop taking the treatment once brain scans no longer show amyloid plaques. Source: Pharma

July 26,2024 New Delhi: Viral hepatitis can lead to serious complications such as liver cirrhosis, cancer, and even death. Despite this, it remains a severely neglected public health concern in India Just recently, I was consulted on the case of a 40-year-old techie diagnosed with cirrhosis of the liver and a large cancerous tumour—a condition that could easily have been prevented with something as simple as early screening and accessible vaccination. With an investment of less than ₹500, these preventive measures could have spared him complications and treatment such as a liver transplant that can cost between ₹20 lakh and ₹40 lakh. This patient ignored swelling in his legs – a key sign of liver failure – for a little more than a year. But a few days ago, when he developed jaundice, he met his physician. A series of tests led us to the tumour in his liver. He had end-stage liver disease and has been waitlisted for a transplant by our medical team. The story of this patient is not new. In many cases, I meet patients for the first time when they are in the intensive care unit. Some are wheeled into the ICU in critical condition after taking treatments including herbal concoctions from quacks. There is evidence that shows how mass screening and vaccinations for hepatitis have been able to cut down on hospitalisations and deaths. World Hepatitis Day is celebrated on July 28 in honour of the birth anniversary of Dr Baruch Blumberg, who discovered the hepatitis B virus in 1967 and developed the vaccine two years later. The day is commemorated by raising awareness about viral hepatitis, a preventable and treatable disease, which causes almost 1.3 million deaths a year worldwide. Viral hepatitis, encompassing hepatitis A, B, C, D, and E, represents a significant and often overlooked public health issue in India. These diseases, which cause liver inflammation, can lead to severe complications such as liver cirrhosis, liver cancer, and death. India bears a significant burden of viral hepatitis. According to World Health Organisation (WHO), India accounts for 10 per cent -15 per cent of the global burden of hepatitis B virus infections. Hepatitis C also presents a major health concern, with an estimated 6 million to 12 million people infected. Poor sanitation, lack of awareness, and inadequate healthcare infrastructure exacerbate the problem. In Tamil Nadu, statistics say that there could be close to 1.5 per cent of people with chronic hepatitis B and 0.5 per cent with hepatitis C virus infection. The govt has launched the National Viral Hepatitis Control Programme (NVHCP) to combat this issue. The programme aims to eliminate hepatitis B and C by 2030 through comprehensive prevention, diagnosis, and treatment strategies. The Tamil Nadu govt has adopted the NVHCP and has been work-ing towards elimination of this dreadful disease, but more needs to be done by the govt and the public sector. If we must achieve these goals, the govt needs to push aggressively for screening for hepatitis B and C and vaccinations against hepatitis B. In the success seen post-COVID vaccinations, several countries such as the UK have started mass vaccinations for hepatitis. We must ensure people, at least those in the 20-59 age group can get their shots, protecting them against this potentially chronic liver disease. The aim is to prevent infection among middle-aged adults with hepatitis B. With rapid lifestyle change, we are increasingly seeing how the disease is impacting people in their 40s and 50s. Mass vaccination camps are the only way we can eliminate hepatitis B in the state and across the country. The vaccine has an outstanding record of safety and effectiveness and has been used worldwide since 1982. The vaccine recommended by WHO is 95 per cent effective in preventing chronic infections from developing. Protection lasts 20 years. The disease is usually treatable, but in some cases it becomes chronic. There are different types of viral hepatitis, each with distinct modes of transmission and health impacts. Hepatitis A is primarily transmitted through the ingestion of contaminated food or water, common in regions with poor sanitation. While typically acute, it does not lead to chronic liver disease; vaccination and improved sanitation are effective preventive measures against it. Hepatitis B spreads through contact with infected body fluids such as blood and semen. It can manifest as both acute and chronic infections, posing a significant risk for liver cirrhosis and cancer. Vaccination is crucial for prevention, with mother-to-child transmission during childbirth a notable concern in India. Hepatitis C is mainly transmitted through blood-to-blood contact, often due to unsafe injection practices, unscreened blood transfusions, and sexual contact. It frequently progresses to chronic infection, causing long-term liver issues. While no vaccine exists, antiviral medications can cure more than 95 per cent of cases. Source: Healthworld

July 26,2024 London: The European Medicines Agency has backed the use of Novo Nordisk’s Wegovy to lower major heart risks and strokes in overweight or obese adults without diabetes, the Danish drugmaker said on Thursday. The backing from the European Union drug watchdog’s committee comes two days after Wegovy secured a similar nod from the UK regulator, while the U.S. Food and Drug Administration approved the drug for prevention of cardiovascular events in people with obesity earlier this year. Novo said it will implement the updated use of Wegovy on its label, or prescribing information, in the EU within about one month. The expanded use is supported by data from a late-stage trial that showed Wegovy reduced the risk of major cardiovascular events such as heart attack and stroke by 20 per cent compared with placebo. The trial enrolled 17,604 adults and was conducted in 41 countries, Novo said. Novo’s widely used diabetes drug Ozempic and weight-loss drug Wegovy, both chemically known as semaglutide, belong to a class of drugs called GLP-1 agonists. Originally developed for type 2 diabetes, they also reduce food cravings and cause the stomach to empty more slowly. Soaring demand for GLP-1 agonists has led to supply constraints for drugmakers such as Novo Nordisk and rival Eli Lilly . Supplies of both Novo’s Wegovy and Lilly’s weight loss drug Zepbound remain constrained, but the companies have been increasing production. Novo’s Wegovy was approved in the EU since 2022, and since June 2021 in the United States. Analysts estimate sales of the drugs to reach $150 billion by the early 2030s. Both Lilly and Novo are also testing their drugs for other health conditions. Source: Pharma

July 26,2024 Palghar: The Food and Drugs Administration (FDA) in Maharashtra conducted raids at three locations in Palghar district and seized material worth Rs 1.41 crore from a pharma company after finding that it did not have a licence to manufacture drugs in the state, officials said on Friday. The raids were conducted in Vasai taluka of the district at the units of Gaharwar Pharma Products Pvt Ltd, they said. The company had obtained a licence to manufacture ayurvedic drugs in Haryana. However, it was producing these medicines in Vasai without the permission to do so, the FDA said in its release. The drugs that were supposed to be manufactured in Haryana were shown to be sold to Onkar Pharma in Punjab. However, Onkar Pharma was found operating from Vasai and was distributing drugs from there by fraudulently showing the place of dispatch as Jalandhar, it said. The value of seized Ayurvedic drugs, raw material, types of machinery, packing material, labels and pouches worth around Rs1.41 crore were seized from the manufacturing unit, it added. Investigation into the case was underway and suitable legal action will be taken against the manufacturer after completion of the probe, it said. Source: Pharma

July 27,2024 New York: A vaccine for shingles may help delay getting dementia diagnosis, according to recent research by Nature Medicine, as reported by CBS News. The research found that the latest shingles vaccine appears to delay the onset of the memory-impairing condition. According to the study published in Nature Medicine on Thursday, the researchers found people who got the vaccine lived, on average, an additional 164 days without a dementia diagnosis compared to those who received the previous shingles vaccines. The results were exciting, Dr Celine Gounder, CBS News medical contributor and editor-at-large for public health at KFF Health News, said on “CBS Mornings”. “The fact that we have a vaccine that’s already approved, already out there, and covered by insurance, super easy to get. The fact that that is showing this kind of level of protection is really promising for a lot,” she said. As an expert reaction, Dr Sheona Scales, the director of research at Alzheimer’s Research UK, shared her insight alongside the study. “Dementia isn’t an inevitable part of ageing; it’s caused by diseases like Alzheimer’s. So finding new ways to reduce people’s risk of developing these diseases is vital,” Scales said. But, it isn’t clear how the vaccine might be reducing risk, Scales continued, adding, “It will be critical to study this apparent effect further.” The authors also note that further research is needed to understand what exactly creates this association, as reported by CBS News. The Centres for Disease Control and Prevention (CDC) already recommend that everyone should get the two-dose shingles vaccine starting at age 50. “I think the real question before us now is, should we be starting to vaccinate even earlier? Will you need more doses if you start vaccinating vaccinating earlier? We don’t have answers to that yet,” Gounder said. Moreover, preventing dementia later in life involves a lot of the same things that experts advise for overall health, reported CBS News. “You want to control your blood pressure, avoid developing diabetes through good diet and exercise, but if you have diabetes, be sure to manage it well, quit smoking,” Gounder said. She further said that a newer risk factor to be aware of is air pollution caused by wildfire smoke. “Try to minimize your exposure, get some indoor air filtration units. You might want to be wearing a mask outdoors during those periods,” Gounder advised. Source: Healthworld

July 27,2024 New Delhi: The Government of India took several initiatives through the ‘Whole of Government’ approach during the COVID-19 pandemic to ensure effective management and availability of sufficient healthcare infrastructure to meet the increased demand during that period. Following are the details of key schemes launched and implemented by the Ministry of Health and Family Welfare to deal with pandemics like COVID-19 and ensure sufficient resources in public health facilities across the country during such pandemics. The Ministry of Health and Family Welfare launched the Pradhan Mantri – Ayushman Bharat Health Infrastructure Mission (PM-ABHIM) on October 25, 2021, with an outlay of Rs. 64,180 crores to be implemented over five years from 2021-22 to 2025-26, to fill critical gaps in health infrastructure, surveillance and health research – spanning both the urban and rural areas. This mission was launched to strengthen the public health infrastructure and to effectively manage and respond towards any future pandemics and outbreaks. The Scheme is a Centrally Sponsored Scheme (CSS) with some Central Sector components. The measures under the scheme focus on developing capacities of health systems and institutions across the continuum of care at all levels viz. primary, secondary and tertiary and on preparing health systems to respond effectively to current and future pandemics/disasters. Under CSS components, support is provided to States/UTs for the construction of Ayushman Arogya Mandir (AAM) in rural and urban areas, establishment/strengthening of Block Public Health Units, Integrated District Public Health Labs in all districts and Critical Care Hospital Blocks. Central Sector Components majorly support interventions focusing on enhancing capacities for Surveillance and Health Emergency Response , Research, Pandemic Preparedness and One Health approach to prevent, detect, and respond to infectious disease outbreaks in animals and humans. The India COVID-19 Emergency Response and Health System Preparedness Package (ECRP-I) for Rs. 15,000 crores were approved by the cabinet on April 22, 2020, to prevent, detect and respond to the threat posed by COVID-19. Further, an amount of Rs. 8473.73 crores has been released to States & UTs. ECRP is a Central Sector Scheme launched in 2020 to provide support to Primary, Secondary and Tertiary healthcare facilities. This scheme is aimed at building a resilient health system to support preparedness and prevention functions for the management of the COVID-19 pandemic and any such future outbreaks in India. Further, to provide support to Central hospital agencies and to States/UT governments to augment their existing response to the second wave and the evolving COVID-19 pandemic, the ECRP, Phase-II was approved by the cabinet on July 8, 2021, with the financial outlay of Rs. 23,123 crores. The ECRP-II has the Central Sector (CS) and Centrally Sponsored Schemes (CSS) components. An amount of Rs. 12740.22 crores has been released to States & UTs under the CSS component. The scheme aimed to accelerate health system preparedness for immediate responsiveness for early prevention, detection, and management of COVID-19, with a focus on health infrastructure development including pediatric care and with measurable outcomes. Source: Healthworld

July 27,2024 New Delhi: The World Health Organisation on Saturday called on countries in the South-East Asia Region to urgently scale up efforts to provide universal access to prevention, vaccination, diagnosis, and treatment of viral hepatitis B and C. Despite being preventable and treatable, these chronic infections are increasingly causing serious illness and deaths from liver cancer, cirrhosis, and liver failure in the region, a press release from WHO said. Today, liver cancer is the fourth biggest cause of cancer deaths in the region, and the second most common cause of cancer deaths among men. Almost 75 per cent of liver cirrhosis is due to hepatitis B and C infection, the press release said. In 2022, the region accounted for 70.5 million people living with viral hepatitis B and C. Early testing and treatment can cure hepatitis C and prevent hepatitis B from causing liver cirrhosis and cancer and can help reverse the predictions that liver cancer rates in South-East Asia Region are set to double by 2050 to over 200,000 deaths annually, the WHO release said. “We have the knowledge and tools to prevent, diagnose and treat viral hepatitis, yet people with chronic hepatitis B and C are still waiting to access the services they need. We need to accelerate efforts to deliver equitable services closer to communities, at the primary health care level,” said Saima Wazed, Regional Director WHO South-East Asia on the World Hepatitis Day. The theme this year is ‘It’s time for action’. Globally, hepatitis B and C combined cause 3,500 deaths per day, with 6,000 people newly infected with viral hepatitis each day. An estimated 254 million people are living with hepatitis B and 50 million people are living with hepatitis C, worldwide. Many people remain undiagnosed, and even when diagnosed, the number of people getting services and receiving treatment remains extremely low. In 2022, about 1.3 million people died of viral hepatitis, the same as deaths caused by tuberculosis. Viral hepatitis and tuberculosis were the second leading causes of death among communicable diseases in 2022, after COVID-19. In WHO South-East Asia Region, the coverage of hepatitis B and C testing and treatment remains low. In 2022, only 2.8 per cent people with hepatitis B were diagnosed, and 3.5 per cent of those diagnosed received treatment. Only 26 per cent and 14 per cent of people with hepatitis C were diagnosed and treated, respectively. “We have safe and effective vaccines that can prevent hepatitis B infection. Antiviral drugs are highly effective in controlling and preventing disease progression , managing chronic hepatitis B and curing most cases of hepatitis C. More needs to be done for these life-saving interventions to benefit each person, irrespective of who they are and where they live,” Wazed said. Hepatitis B and C affect the general population and specific populations such as those at higher risk of or with a history of exposure through unsafe blood supplies, unsafe medical injections and other health procedures; newborns and children at risk through mother-to-child transmission of hepatitis B and C, notably in settings with high viral hepatitis prevalence; indigenous populations and mobile and migrant populations from countries with higher prevalence; and key populations, including people who inject drugs, people in prisons and other closed settings and sex workers. It is important to keep the needs of people living with viral hepatitis at the centre of all efforts, and for all stakeholders, including the private sector, to work together at all levels to reverse the current impact on health. Results from several country investment case studies suggest that there is an estimated return on investment of USD 2-3 for every dollar invested in the viral hepatitis response to reverse the increasing mortality and prevent large costs of cancer treatment and care. “Viral hepatitis is a major public health challenge of this decade. With public health approach and leveraging countries’ investments in universal health coverage, elimination of viral hepatitis by 2030 is feasible,” the Regional Director of WHO, said. Source: Healthworld

July 23,2024 New Delhi: Cough syrup samples collected from more than 100 pharma units in the country have failed quality tests, according to a government report, which highlights that some had the same toxins that were found in the cough syrups that were linked to deaths of children in Gambia, Uzbekistan and Cameroon. According to the Central Drugs Standard Control Organisation’s report, the sub-standard batches were declared as “not of standard quality” (NSQ) for parameters such as diethylene glycol (DEG) or ethylene glycol (EG). It flagged it as a “matter of concern”. The report, which was presented in the health ministry, said the batches of cough syrups were declared as NSQ for parameters such as DEG/EG, assay, microbial growth, pH and volume. Out of the 7,087 batches analysed, 353 were declared as NSQ, while nine failed on account of the presence of DEG and EG. The reasons for failure on account of DEG/EG, as per the report, were “unsecured supply chain and failure to test the propylene glycol bulk for DEG/EG, among others”. Various laboratories, including the government-run and the private labs-across the country, have been conducting tests in the aftermath of reports linking India-made cough syrups to 141 child fatalities globally. India-manufactured cough syrups have been under the scanner after the World Health Organisation (WHO) in October 2022 said deaths of about 70 children in Gambia from acute kidney injury (AKI) might be linked to cough and cold syrups made by Indian manufacturers. The CDSCO, with the help of state drug control departments, has been carrying out inspections of the cough syrup manufacturing units and distributors of propylene glycol to map the supply chain. “The manufacturers have been sensitised on the use of pharma-grade propylene glycol,” an official said. In May last year, the Drugs Controller General of India (DCGI) had asked state drug controllers “to give instructions to their state-owned NABL-accredited laboratories to analyse the samples received from the manufacturers of cough syrups for export purpose on top priority and issue the test report at the earliest”. The Directorate General of Foreign Trade (DGFT) had also made it mandatory for exporters of cough syrups to get them tested at government laboratories and produce a certificate of analysis (CoA), effective last June. An investigation by United States Centres for Disease Control and Prevention and Gambian scientists into the deaths in the small west African country had “strongly suggested” that imported medications contaminated with diethylene glycol (DEG) and ethylene glycol (EG) led to AKI clusters among children. Source: Healthworld

July 25,2024 New Delhi: Union Finance Minister Nirmala Sitharaman presented the Union Budget on Tuesday, announcing customs duty exemptions on three cancer drugs to make them more affordable for patients. Indian Medical Association (IMA) President Dr RV Asokan said that the budget maintains the status quo for health concerns, highlighting the import duty reductions on X-ray components and cancer drugs. “This budget is status quo for health concerns, with only two silver linings: customs duty exemptions on diagnostics and cancer drugs. The economy has moved from USD 3.4 trillion to USD 4 trillion,” said Dr Asokan. “The amount of investment that governments bring out, the total national health expenditure, is around four per cent of the GDP, which works out to 13 lakh crores,” he added. “The investment in health by governments has been stagnant at 1.1 per cent of GDP. Out of this 1.1 per cent, one-third comes from the central government and two-thirds come from state governments. We are a USD 4 trillion economy. 1.1 per cent of the GDP is 3.6 lakh crores. Taking into consideration the inflation and expansion of the economy, the allocation of the health budget has gone down,” he said. “The programmes announced in the previous budget, like HPV vaccination and sickle cell disease intervention, have not been rolled out in the field,” the IMA President noted. Dr Roderico H Ofrin, the World Health Organisation (WHO) Representative to India, also praised the customs duty exemptions on three cancer treatment drugs as a commendable step. Speaking with ANI, Ofrin said, “The significant boost in fund allocation for health, including AYUSH, underscores the government’s commitment to health promotion, disease elimination, and strengthening public healthcare services.” He added, “Additionally, customs duty exemptions on three cancer treatment drugs demonstrate a focused effort to make life-saving treatments more affordable and accessible. These actions are commendable steps towards health for all.” Source: Healthworld

July 12,2024 BioArctic AB’s (publ), a Swedish research-based biopharma company, announced that its partner Eisai receives approval from the Department of Health in Hong Kong for Leqembi (generic name: lecanemab) for treatment of Alzheimer’s disease (AD). Treatment with Leqembi should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. Hong Kong is the fifth approval following the US, Japan, China and South Korea. Leqembi’s approval in Hong Kong is based on the large global phase 3 Clarity AD study. In the Clarity AD study, Leqembi met its primary endpoint and all key secondary endpoints with statistically significant results. In Hong Kong, 9.3% of people aged 70 years and older are living with dementia, and 32% of those aged 85 years and older, of whom 73.5% are reported to have Alzheimer’s disease. Leqembi selectively binds to soluble amyloid-beta (Aß) aggregates (protofibrils), as well as insoluble Aß aggregates (fibrils) which are a major component of Aß plaques in AD, thereby reducing both Aß protofibrils and Aß plaques in the brain. Leqembi is the first approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism. Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer’s disease. Eisai is responsible for the clinical development, applications for market approval and commercialization of Lecanemab for Alzheimer’s disease. BioArctic has no development costs for Leqembi in Alzheimer’s disease and is entitled to payments in connection with certain regulatory approvals, and sales milestones as well as royalty of 9 percent on global sales. In addition, BioArctic has the right to commercialize Leqembi in the Nordic region, pending European approval, and currently Eisai and BioArctic are preparing for a joint commercialization in the region. Lecanemab (Leqembi) is the result of a strategic research alliance between BioArctic and Eisai. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aß). Lecanemab is also approved in the US, Japan, China, and South Korea with the following indications: US: For the treatment of Alzheimer’s disease (AD). It should be initiated in patients with mild cognitive impairment or mild dementia stage of disease. Japan: For slowing progression of mild cognitive impairment (MCI) and mild dementia due to AD. China: For the treatment of MCI due to AD and mild AD dementia. South Korea: For treatment in adult patients with mild cognitive impairment due to Alzheimer’s disease (AD) or mild AD (early AD) Lecanemab approvals were based on the large global phase 3 Clarity AD study. In the Clarity AD study, lecanemab met its primary endpoint and all key secondary endpoints with statistically significant results. In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer’s Disease (CTAD) conference, and simultaneously published in the New England Journal of Medicine, a peer-reviewed medical journal. Eisai has also submitted applications for approval of lecanemab in 13 countries and regions, including the European Union (EU). A supplemental Biologics License Application (sBLA) for intravenous maintenance dosing was submitted to the US Food and Drug Administration (FDA) in March 2024. The rolling submission of a Biologics License Application (BLA) for maintenance dosing of a subcutaneous injection formulation, which is being developed to enhance convenience for patients, was initiated in the US under Fast Track status in May 2024. Since July 2020 Eisai’s phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer’s Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the US, funded by the National Institute on Aging, part of the National Institutes of Health and Eisai. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy. Since 2005, BioArctic has a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer’s disease. The most important agreements are the development and Commercialization Agreement for the lecanemab antibody, which was signed 2007, and the development and commercialization agreement for the antibody Leqembi back-up for Alzheimer’s disease, which was signed 2015. In 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer’s disease. BioArctic has the right to commercialize lecanemab in the Nordic region and is currently preparing for commercialization in the Nordics together with Eisai. BioArctic has no development costs for lecanemab in Alzheimer’s disease and is entitled to payments in connection with regulatory approvals, and sales milestones as well as royalties on global sales. BioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. Source: Pharmabiz