(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.
The approval of ruxolitinib cream, a JAK inhibitor, serves as a relief to the class of treatments that work by blocking inflammation-causing enzymes Janus kinases.
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.
For Opzelura, the health regulator has flagged serious side effects, common to oral JAK inhibitor drugs, including an increased risk of heart attack, stroke or cardiac death.
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.
The cream is also being tested for teenagers and adults with vitiligo, a disease that causes loss of skin color.
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.
Novartis AG markets the drug overseas as Jakavi.
(Reporting by Bhanvi Satija and Manojna Maddipatla; Editing by Vinay Dwivedi)
