Sun Pharma Gets US FDA Approval for Baldness Drug

On Friday, Sun Pharma announced that the US Food and Drug Administration (FDA) approved their new drug, Leqselvi (deuruxolitinib) 8 mg tablets, for treating severe alopecia areata (patchy baldness) in adults. This approval is a big step for Sun Pharma, which paid $576 million (Rs 4600 crore) in January 2023 to buy Concert Pharmaceuticals and acquire deuruxolitinib, described as a “potential best-in-class” therapy.

Shares of Sun Pharma rose by 2.58%, trading at Rs 1708.20 at 11.10 am, while the Sensex gained 0.84% to reach 80,710.90 points.

About Deuruxolitinib:

• Deuruxolitinib is a twice-daily oral selective inhibitor of Janus Kinases (JAK) JAK1 and JAK2.
• It treats moderate to severe alopecia areata, an autoimmune disease where the immune system attacks hair follicles, causing partial or complete baldness.
• The disease affects up to 2.5% of the US population, with limited treatment options available.

Sun Pharma will have exclusive marketing rights for the product for five years.

Comments from Sun Pharma:

Abhay Gandhi, CEO of Sun Pharma’s North America Business, said in May that they were fully prepared to market the drug. Deuruxolitinib is expected to significantly boost Sun Pharma’s global specialty business, which reached $1 billion in sales in FY24. Jefferies forecasts that Deuruxolitinib could achieve sales of $765 million in the US and European markets by 2031, with a pre-tax net present value of Rs 64 per share.

Global specialty sales, which made up about 18% of Sun Pharma’s revenue, grew by 19% year-on-year 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.”

Approval Details:

The FDA’s approval is based on data from two Phase 3 clinical trials, THRIVE-AA1 and THRIVE-AA2, involving 1,220 patients with alopecia areata who had at least 50% scalp hair loss for more than six months. Additional data were collected from two long-term extension trials.

At the start of the trials, the average patient had only 13% scalp hair coverage. After 24 weeks, over 30% of patients taking Leqselvi experienced 80% or more scalp hair coverage, with some patients regaining nearly all of their scalp hair.

“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% of patients had almost all of their scalp hair back at 24 weeks,” the company said.