- Eli Lilly’s autoimmune disease drug baricitinib spurred hair regrowthin patients with a severe form of alopecia areata in a second Phase 3 study, positioning the drug to become the first treatment specifically approved for the disease.
- Lilly and partner Incyte announced successful findings from the first Phase 3 study last month. But with the new results in hand, the Indianapolis drugmaker now plans to seek U.S. clearance for the treatment, which is approved for rheumatoid arthritis as Olumiant. Lilly will file an application in the second half of the year.
- Lilly’s drug is one of three so-called JAK inhibitors in advanced testing for alopecia areata, an autoimmune disease that causes patches of hair loss. Each has shown the potential to regrow hair, but could nonetheless face regulatory and commercial challenges, as the Food and Drug Administration has expressed a clear concern with the safety profile of the drug class.