FDA Approves Leqselvi for Severe Hair Loss

FRIDAY, Aug. 2, 2024 -- The U.S. Food and Drug Administration has given the green light to Leqselvi (deuruxolitinib) tablets for adult patients suffering from severe alopecia areata. Leqselvi is an oral medication taken twice daily, specifically targeting the Janus kinases JAK1 and JAK2.

Clinical trials have shown that the most frequent side effects associated with Leqselvi are headache, acne, and nasopharyngitis. The approval is supported by findings from the THRIVE-AA1 and THRIVE-AA2 clinical trials, both of which were randomized, double-blind, and placebo-controlled phase 3 studies. These trials involved 1,220 individuals who had experienced at least 50 percent hair loss on their scalp for a period exceeding six months.

During the 24-week trials, over 30 percent of patients who took Leqselvi showed significant improvement, achieving 80 percent or more scalp hair coverage, measured using the Severity of Alopecia Tool (SALT) score. Remarkably, up to 25 percent of patients nearly regained all their scalp hair, attaining 90 percent or more coverage by the end of the 24-week period. Furthermore, the proportion of patients achieving a SALT score of 20 or lower did not plateau throughout the trial duration, indicating continuous improvement.

Dr. Natasha Mesinkovska, a researcher from the University of California, Irvine, and a key investigator in the Leqselvi clinical development program, emphasized the importance of early intervention for those with severe alopecia areata. She stated, "An oral JAK that delivers proven results will be impactful for the alopecia areata community." 

Sun Pharma is the recipient of the FDA approval for Leqselvi, marking a significant advancement in the treatment options available for severe alopecia areata.

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