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FDA Approves First Medicine Ever For Alopecia Areata

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The FDA has approved Eli Lilly and Co. (LLY) and Incyte Corp.'s (INCY) Olumiant for yet another indication, this time, for the treatment of adult patients with severe alopecia areata.

Olumiant, an oral JAK1/JAK2 inhibitor, becomes the first and only *systemic treatment for alopecia areata, an autoimmune disease that often appears as patchy baldness.
*Drug therapies that function throughout the body are known as systemic treatments).
It is estimated that about 700,000 people are living with alopecia areata in the U.S.

The drug was discovered by Incyte Corp. (INCY) and licensed to Eli Lilly and Co.

The approval was based on Lilly's largest phase III alopecia areata clinical trial program, which comprised of two studies, dubbed BRAVE-AA1 and BRAVE-AA2. This phase III program evaluated Olumiant in 1,200 adult patients with severe alopecia areata.

Across the two studies at 36 weeks, 17-22% of patients taking Olumiant 2-mg/day and 32-35% of patients taking Olumiant 4-mg/day achieved 80% or more scalp hair coverage, compared to 3-5% taking placebo, according to the company.

Olumiant sports a boxed warning for risk of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE) and thrombosis.

The drug received its initial approval in May 2018 for the treatment of rheumatoid arthritis. Last month, Olumiant was approved for the treatment of COVID-19 in certain hospitalized adults.

For the first quarter of 2022, worldwide Olumiant revenue was $255.6 million, an increase of 32% over the year-ago quarter.

Last month, the European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion for Olumiant for the treatment of adults with severe alopecia areata. The European Commission is expected to announce its decision this month or next.

LLY closed Monday's trading at $291.28, down 1.93%.

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