Eli Lilly Gets FDA Approval for First Autoimmune Alopecia Drug

June 14, 2022

The US Food and Drug Administration (FDA) has approved Eli Lilly’s drug Olumiant for alopecia areata (AA), an autoimmune disorder that causes significant hair loss. The approval is a major win for Lilly, which was racing against Pfizer and Concert Pharmaceuticals to bring the first therapeutic to market for AA. The drug was previously approved for other purposes, including rheumatoid arthritis and COVID-19.

According to, “Monday’s approval comes after Lilly submitted results of two double-blind, placebo-controlled Phase III trials, enrolling 1,200 adult patients with severe AA (measured by at least 50% scalp hair loss). Those patients were randomized to receive once-daily Olumiant at 2 mg, 4 mg or placebo.”

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(Source: Endpoints News, June 14th, 2022)

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