Leqselvi is now FDA approved for treating severe alopecia areata. Sun Pharma added the oral drug to its pipeline via the $576 million acquisition of Concert Pharmaceuticals last year.

By Frank Vinluan Hair loss caused by alopecia areata now has a new FDA-approved treatment, a third-in-class drug from Sun Pharmaceutical Industries that will compete against commercialized medicines from Eli Lilly and Pfizer.
The regulatory decision announced Friday for the drug, deuruxolitinib, covers the treatment of adults with severe alopecia areata. Mumbai, India-based Sun Pharma, which has U.S. operations in Princeton, New Jersey, will market the twice-daily pill under the brand name Leqselvi.
Alopecia areata is a condition in which the immune system attacks hair follicles, causing sudden hair loss. The disorder affects both males and females. While the hair loss mainly happens on the scalp, the condition can affect other parts of the body. Sun Pharma cites studies estimating that 700,000 people in the U.S. are affected by alopecia areata; of those, 300,000 people have what’s classified as severe alopecia areata.
The available treatments for alopecia areata include topical drugs, such as corticosteroids. Leqselvi is an oral small molecule designed to block Janus kinases (JAK), proteins that play a role in inflammatory pathways in the body. JAK inhibitors have been approved for several autoimmune conditions. By blocking JAK1 and JAK2 proteins, Leqselvi is intended to interrupt pathways thought to contribute to hair loss in severe cases of the condition.
The FDA approval is based on results from two placebo-controlled Phase 3 studies. These studies enrolled 1,220 patients whose alopecia areata led to at least 50% scalp hair loss for more than six months. At the baseline of the studies, patients on average had only 13% scalp coverage. Results showed that at 24 weeks, more than 30% of participants treated with Leqselvi achieved scalp coverage of 80% or more, meeting the main goal of the study.
“For many people with severe alopecia areata, early intervention with effective treatment is critical,” said Natasha Mesinkovska, associate professor and vice chair for clinical research of dermatology, University of California, Irvine, and an investigator in the Leqselvi clinical trials, said in a prepared statement. “An oral JAK that delivers proven results will be impactful for the alopecia areata community.”
The most common adverse events reported in the clinical trials were headache, acne, and nasopharyngitis. Leqselvi’s label carries a black box warning that cautions prescribers and patients about the risk of cancer and cardiovascular events. It’s a class-wide warning the FDA now requires for all JAK inhibitors.
In 2022, Eli Lilly JAK inhibitor baricitinib, brand name Olumiant, became the first systemic drug approved for treating severe alopecia areata in adults. Last year, the FDA approved the Pfizer JAK inhibitor litlecitinib, brand name Litfulo, for severe alopecia areata in patients age 12 and older. Both drugs are once-daily pills, so Sun Pharma’s twice-a-day product is at a dosing disadvantage. Sun Pharma could compete on price. But in an email, a Sun Pharma spokesperson declined to divulge pricing details, saying only that the company is “collaborating with payers to ensure affordability and equitable access to Leqselvi in the U.S.” The spokesperson added that the timing of a product launch has not yet been confirmed.
Sun Pharma added Leqselvi to its pipeline last year via the acquisition of the drug’s developer, Lexington, Massachusetts-based Concert Pharmaceuticals. Sun Pharma paid $8 for each Concert share, amounting to about $576 million. The deal includes a contingent value right that calls for an additional payout of $3.50 for each Concert share if Leqselvi achieves sales milestones.
Photo by FDA