BILKULONLINE
Mumbai, India and Princeton, N.J., July 27: Sun Pharmaceutical Industries Limited has announced that the U.S. Food and Drug Administration (FDA) has approved LEQSELVI™ (deuruxolitinib) 8 mg tablets for the treatment of severe alopecia areata in adults. This approval follows positive results from two Phase 3 clinical trials, which demonstrated statistically significant efficacy.
Alopecia areata, affecting approximately 700,000 people in the U.S., can cause substantial emotional and psychological distress. LEQSELVI, an oral selective JAK inhibitor, addresses this need by targeting the pathways associated with hair loss in severe cases. Clinical trials revealed that one-third of patients achieved 80% scalp hair coverage within 24 weeks of treatment, with up to 25% experiencing nearly complete scalp hair restoration.
Abhay Gandhi, CEO of Sun Pharma’s North America Business, highlighted the potential of LEQSELVI to provide a much-needed option for patients who have struggled with existing treatments. The drug’s approval is supported by data from multicenter, randomized, double-blind, placebo-controlled trials involving 1,220 patients.
The National Alopecia Areata Foundation (NAAF) welcomed the approval, recognizing it as a significant advancement for the alopecia community. However, LEQSELVI may have serious side effects including infections, malignancies, and cardiovascular events, and is not recommended for all patients.
Sun Pharma plans to introduce an access program to assist eligible patients with their treatment journey. For more information, visit www.LEQSELVI.com.