Sun Pharmaceutical Industries Ltd. (SUNPHARMA, 524715) announced on Friday that the U.S. Food and Drug Administration has granted approval for Leqselvi 8 mg tablets. This medication is indicated for the treatment of adults with severe alopecia areata, a prevalent autoimmune disorder.
The approval was supported by the results of Phase 3 clinical trials, THRIVE-AA1 and THRIVE-AA2, which included alopecia areata patients experiencing at least a 50 percent loss of scalp hair.
By the end of the 24-week trials, over 30 percent of the participants achieved 80 percent or more scalp hair coverage. Additionally, up to 25 percent of the patients had nearly fully restored scalp hair.