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FDA approves Incyte’s eczema cream By Reuters


© Reuters. FILEPHOTO: This sign can be seen at White Oak (Maryland), U.S.A) on August 29, 2020. REUTERS/Andrew Kelly

(Reuters) -The U.S. Food and Drug Administration on Tuesday approved Incyte (NASDAQ:) Corp’s cream Opzelura for treating inflammatory skin condition atopic dermatitis, commonly called eczema, in adolescents and adults.

Ruxolitinib cream is a JAK inhibitor and has been approved. It will provide relief for the treatment class that works by inhibiting inflammation-causing enzymes Janus kinases.

Recent safety concerns over oral JAK inhibitors such as Pfizer Inc (NYSE:)’s arthritis drug Xeljanz and AbbVie Inc (NYSE:)’s treatment Rinvoq and Eli Lilly (NYSE:)’s Olumiant, have led to regulatory delays.

Opzelura was notified by the regulator of serious side effects that oral JAK inhibitors can cause, which include an increase in heart attacks, strokes, and cardiac deaths.

Chronic skin conditions such as atopic dermatitis can cause skin irritation and inflammation. It affects about 30% of the U.S. population, mostly children and adolescents, according to the National Institute of Allergy and Infectious Diseases https://

The cream is also being tested for teenagers and adults with vitiligo, a disease that causes loss of skin color.

Ruxolitinib has been approved in the United States as an oral tablet, under the name Jakafi. It is used to treat a rare form of cancer known as polycythemia vera.

Novartis AG sells the drug as Jakavi overseas.

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