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FDA Approves Lilly's Olumiant As First Systemic Treatment For Alopecia

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The U.S. Food and Drug Administration approved Eli Lilly and Co.'s Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata, a disorder that often appears as patchy baldness.

This is the first FDA approval of a systemic treatment, i.e. treats the entire body rather than a specific location, for alopecia areata.

Alopecia areata, commonly referred to as alopecia, is an autoimmune disorder in which the body attacks its own hair follicles, causing hair to fall out, often in clumps. The decease affects more than 300,000 people in the U.S. each year.

Olumiant is a Janus kinase or JAK inhibitor discovered by Incyte and licensed to Lilly. It blocks the activity of one or more of a specific family of enzymes, interfering with the pathway that leads to inflammation.

The FDA's decision is based on two randomized, double-blind, placebo-controlled trials in which the efficacy and safety of Olumiant in alopecia areata was studied in patients who had at least 50% scalp hair loss.

In these Trial AA-1 and Trial AA-2, patients received either a placebo, 2 milligrams of Olumiant, or 4 milligrams of Olumiant every day. The primary measurement of efficacy for both trials was the proportion of patients who achieved at least 80% scalp hair coverage at week 36. In both trials, a good number of patients achieved adequate scalp hair coverage, compared to those who received a placebo.

In February 2022, the FDA granted priority review for Olumiant in adults with severe AA.

Olumiant was originally approved in 2018 as a treatment for certain adult patients with moderately to severely active rheumatoid arthritis. The drug is also approved for the treatment of COVID-19 in certain hospitalized adults.

Lilly has submitted applications for regulatory approval or authorization to multiple regulatory agencies around the world and anticipates further regulatory decisions to follow.

In mid-May, the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP issued a positive opinion for Olumiant for the treatment of adults with severe alopecia areata. The European Commission's decision is expected in the next one to two months.

Baricitinib has been available in the U.S. under Emergency Use Authorization or EUA since November 2020.

Olumiant is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants. It comes with a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis.

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