Sun Pharma’s $576 million acquisition of Concert Pharmaceuticals is paying off with an FDA approval of the alopecia drug that came with the 2023 deal.
The agency approved the tablet Leqselvi (deuruxolitinib) for the treatment of adults with severe alopecia areata, an autoimmune disease that causes hair loss. According to Sun Pharma, around 700,000 people in the US have alopecia and about 300,000 have the severe form of the disease.
Approval of Leqselvi, a JAK inhibitor, was based on data from two Phase 3 clinical trials that enrolled patients with at least 50% hair loss. The studies met the primary endpoints, with more than 30% of the participants gaining 80% or more coverage of scalp hair. Also, up to 25% of participants had almost all of their hair back after 24 weeks.
Like other JAK inhibitors, Sun’s drug comes with a boxed warning for serious infections, mortality, malignancies, major adverse cardiovascular events and thrombosis. In May, the FDA put a partial hold on the 12 mg dose of the drug after a patient in an open-label extension trial experienced a pulmonary embolism (the approval covers the 8 mg dose).
In the Phase 3 trials as well as a Phase 2 trial, 3.1% of patients discontinued due to adverse events. The most common were headache, acne and colds.
Sun Pharma’s acquisition of Concert and Leqselvi was part of the Mumbai-based company’s plan to build a dermatology and ophthalmology franchise. But Sun must compete against Eli Lilly’s JAK inhibitor Olumiant, which in 2022 became the first drug approved to treat alopecia. Then Pfizer’s Litfulo was approved in 2023 for people 12 years and older with the condition, winning the broadest label on the market. Sun and Lilly’s drug is only for adults.