Sun Pharma's Leqselvi gets FDA approval for severe alopecia

Sun Pharmaceutical has announced that the FDA has approved Leqselvi (deuruxolitinib), an oral JAK 1/2 inhibitor, for the treatment of severe alopecia areata in adults. The drug will be marketed as an 8 mg tablet to be taken twice daily. This addition to Sun Pharmaceutical's product lineup came through the acquisition of Concert Pharmaceuticals early last year.

According to Abhay Gandhi, the chief executive of Sun Pharmaceutical's North America unit, "Leqselvi offers a new and effective solution for long-suffering patients battling severe alopecia areata and their physicians."

Leqselvi is joining a competitive market as it is the third oral JAK inhibitor approved for treating severe alopecia. It will compete with Eli Lilly and Incyte's JAK1/2 inhibitor Olumiant (baricitinib), which was cleared by the FDA in 2022, and Pfizer's JAK3 inhibitor Litfulo (ritlecitinib), the first therapy approved for adolescents with the condition last year.

The FDA's approval of Leqselvi is based on the results of two Phase III trials, THRIVE-AA1 and THRIVE-AA2. These studies involved 1220 patients suffering from alopecia areata with at least 50% scalp hair loss for over six months, as measured by the Severity of Alopecia Tool (SALT). At the 24-week mark, more than 30% of the patients who were treated with Leqselvi achieved the primary goal of 80% or more scalp hair coverage (SALT ≤20). Additionally, the number of patients reaching a SALT score of ≤20 consistently increased throughout the 24 weeks of treatment without plateauing. Up to 25% of the patients regained 90% or more of their scalp hair by week 24.

However, Sun Pharmaceutical highlighted that Leqselvi comes with a boxed warning about serious potential side effects. These include infections, malignancies, thrombosis, gastrointestinal perforations, and laboratory abnormalities. There are also increased risks for mortality and major cardiovascular events.

The development of Leqselvi faced a challenge last May when the FDA placed a partial clinical hold on the 12-mg dose due to concerns about thrombotic events. Sun Pharmaceutical noted that there were no cases of thrombosis associated with the 8-mg dose, which was the only dose submitted for FDA review. This dose was subsequently accepted for review by the agency in October.