FDA approves Incyte's eczema cream with boxed warnings

FILE PHOTO: Signage is seen outside of FDA headquarters in White Oak, Maryland

By Bhanvi Satija and Manojna Maddipatla

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

The label for Opzelura carries the health regulator's JAK-class warning, flagging risks of serious infections, increased risk of heart attack, stroke or cardiac death.

Shares in the company, which expects to make the cream available in U.S. pharmacies in the coming weeks, were down about 5% at $72.26 after the bell.

RBC analyst Brian Abraham said in a client note that boxed warnings could have a limiting impact on both the long-term opportunity and near-term stock reaction.

The brokerage's physician survey had indicated that a boxed warning on Opzelura's label could reduce adoption by about 30%, particularly in more mild patients, said Abraham in client note.

The ruxolitinib cream is the first topical JAK inhibitor, a class of treatments that work by blocking inflammation-causing enzymes Janus kinases, to be approved in the United States.

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

Atopic dermatitis is a chronic skin condition that causes inflammation and irritation of skin. It affects about 30% of the U.S. population, mostly children and adolescents, according to the National Institute of Allergy and Infectious Diseases https://bit.ly/3tLX6mb.

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 vera, rare bone marrow cancer myelofibrosis and acute Graft-Versus-Host Disease.

RBC's Brian estimates U.S. sales of more than $550 million out-year for the atopic dermatitis indication.

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

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