FDA Approves Incyte Eczema Cream with Boxed Warnings

Signage can be seen outside the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, USA on August 29, 2020. REUTERS / Andrew Kelly

Sept. 21 (Reuters) – The U.S. Food and Drug Administration on Tuesday approved Opzelura Cream from Incyte Corp (INCY.O) for the treatment of inflammatory atopic dermatitis, commonly known as eczema, in adolescents and adults with boxed warnings.

Opzelura’s label carries the health regulator’s JAK class warning, signaling the risks of serious infections, increased risk of heart attack, stroke, or cardiac death.

Shares of the company, which plans to make the cream available at U.S. drug stores in the coming weeks, fell about 5% to $ 72.26 after the bell.

RBC analyst Brian Abraham said in a note to a client that boxed warnings may have limited impact on long-term opportunities and short-term stock reaction.

The brokerage’s physician survey had indicated that a boxed warning on Opzelura’s label could reduce adoption by about 30%, especially in lighter patients, Abraham said in a note. customer.

Ruxolitinib cream is the first topical inhibitor of JAK, a class of treatments that work by blocking inflammatory enzymes Janus kinases, to be approved in the United States.

Recent safety concerns regarding oral JAK inhibitors such as the arthritis drug from Pfizer Inc (PFE.N) Xeljanz and the treatment Rinvoq from AbbVie Inc (ABBV.N) and Eli Lilly (LLY.N) Olumiant , have resulted in regulatory delays. Read more

Atopic dermatitis is a chronic skin condition that causes inflammation and irritation of the skin. It affects about 30% of the American population, mostly children and adolescents, according to the National Institute of Allergy and Infectious Diseases.

Ruxolitinib is approved as an oral tablet under the brand name Jakafi in the United States for the treatment of a type of blood cancer called polycythemia essential, rare myelofibrosis in bone marrow cancer, and acute graft-versus-bone disease. host.

Brian of RBC estimates US sales at over $ 550 million for the year for the atopic dermatitis indication.

Reporting by Bhanvi Satija and Manojna Maddipatla; Editing by Aditya Soni and Vinay Dwivedi

Our Standards: Thomson Reuters Trust Principles.

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