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