Eli Lilly Gets Expanded Label Approval from FDA for Alopecia Drug

Dow Jones05:26

Eli Lilly received expanded label approval from the Food and Drug Administration for Olumiant, a drug for pediatric patients 12 years of age or older with severe alopecia areata.

The company said Friday that the FDA had approved the expanded U.S. label for the drug, known generically as baricitinib, based on the results of a Phase 3 study. Olumiant was previously approved for adults with moderately to severely active rheumatoid arthritis and severe alopecia areata.

"The visible and often extensive hair loss that comes with severe alopecia areata can have a profound impact on anyone, especially adolescents who are at a pivotal stage of life," Lilly Immunology president Adrienne Brown said. "Expanding Olumiant to patients as young as 12 provides them a much-needed treatment choice and reinforces our commitment to advancing care for people living with immune-mediated diseases."

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