Medical Technology

Europe Approves Abrocitinib for Atopic Dermatitis

The oral Janus kinase 1 inhibitor abrocitinib has been approved in Europe for treatment of moderate to severe Atopic dermatitis (AD) in adults, who are candidates for treatment with systemic therapy, the manufacturer announced.

Approval by the European Commission was based on the findings of studies that include four clinical trials in the phase 3 ( JADE MONO-1, JADE-MONO-2, JADE COMPARE, JADE REGIMEN) and an ongoing open-label extension study (JADE EXTEND) in over 2,800 patients, according to the Pfizer press release that announced the approval. According to the press release, the approved doses were 100 and 200 mg daily. A 50-mg dose was approved in patients with moderate or severe renal impairment as well as “certain patients receiving treatment for inhibitors of cytochrome P450 2C19 (CYP 2C19)”.

This approval follows a positive opinion from the Committee for Medicinal Products for Human Use of European Medicines Agency supporting marketing authorization for AD treatment, which was issued in October. It will be called Cibinqo.

Abrocitinib is currently under review by the Food and Drug Administration. It was approved in 2021 to treat AD in the United Kingdom and Japan.

This article originally appeared on MDedge.com, part of the Medscape Professional Network.

Content Source: https://www.medscape.com/viewarticle/964706?src=rss

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