INCY Incyte Corporation

By Michael Dabaie

Eli Lilly & Co. and Incyte Corp. said 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 opinion marks the first step toward European regulatory approval of Olumiant for patients with severe AA. It is now referred to the European Commission for final action.

The companies said they expect the European Commission's decision in the next one to two months.

"Alopecia areata is an often-misunderstood autoimmune disease that can lead to unpredictable hair loss, ranging from bald patches to complete loss of all hair. The disease carries significant psychosocial burden and can impact patients of any race, ethnicity, or age, with many experiencing alopecia in their early to mid-20s," said Bianca Maria Piraccini, professor and head of the Dermatology Unit at the University of Bologna.

Alopecia recently was in the news after actor Will Smith confronted comedian Chris Rock at the 94th Academy Awards for making a joke about his wife, Jada Pinkett Smith, who reportedly has the disease.

In February, the U.S. Food and Drug Administration granted priority review for Olumiant in adults with severe AA. Lilly expects additional regulatory decisions in the U.S. and Japan in 2022.

Lilly and Incyte in 2009 entered a license and collaboration agreement for the development and commercialization of Olumiant.

Write to Michael Dabaie at michael.dabaie@wsj.com

(END) Dow Jones Newswires

May 20, 2022 08:50 ET (12:50 GMT)

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