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The drug received priority review and breakthrough therapy designations for the indication, and approval was granted to Daiichi Sankyo four months ahead of the Prescription Drug User Fee Act deadline.

“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” said Kendall Marcus, M.D., director of the Division of Dermatology and Dentistry in the FDA’s Center for Drug Evaluation and Research, adding that the approval fulfills a significant unmet need for patients with severe alopecia areata.