Sun Pharmaceutical Industries has received U.S. Food and Drug Administration’s (USFDA) approval for LEQSELVI (deuruxolitinib) 8 mg tablets for the treatment of adults with severe alopecia areata. Alopecia areata affects around 700,000 people in the United States, and 300,000 have severe alopecia areata. Alopecia often leads patients to self-treat before seeking professional help, driven by dissatisfaction with the slow progress of existing treatments.
Alopecia areata is a common autoimmune disease in which hair loss is thought to occur due to the collapse of immune privilege, leading to the immune system targeting the hair follicles and causing sudden hair loss on the scalp, face and sometimes other areas of the body. LEQSELVI is a new, twicedaily oral selective inhibitor of Janus Kinases (JAK) JAK1 and JAK2. As a JAK inhibitor, LEQSELVI interrupts the pathways thought to contribute to hair loss in severe alopecia areata.
The approval is based on data from two multicenter, randomized, 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% 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.
Sun Pharmaceutical Industries is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company.
Company Name | CMP |
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Sun Pharma Inds. | 1823.35 |
Dr. Reddys Lab | 6669.75 |
Cipla | 1614.30 |
Lupin | 2258.00 |
Zydus Lifesciences | 1099.50 |
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