FDA Extends Review Period on Pfizer Drug Applications for Abrocitinib, Xeljanz/Xeljanz XR

By Robb M. Stewart

Pfizer Inc. said the U.S. Food and Drug Administration has extended the review period for a pair of drug applications, moving the Prescription Drug User Act goal date for both out to early in the third quarter.

The FDA extended its priority review period for Pfizer's new drug application for abrocitinib for the treatment of adults and adolescents with moderate to severe atopic dermatitis, and also extended the review period for supplemental new drug applications for Xeljanz/Xeljanz XR for the treatment of adults with active ankylosing spondylitis by three months, the drug company said Wednesday.

Abrocitinib is an oral small molecule that selectively inhibits Janus kinase 1, inhibition of which is thought to modulate multiple cytokines involved in pathophysiology of atopic dermatitis, Pfizer said. Xeljanz is approved in the U.S. in four indications--adults with moderately to severely active rheumatoid arthritis after methotrexate failure, adults with active psoriatic arthritis after disease modifying antirheumatic drug failure, adults with moderately to severely active ulcerative colitis after tumor necrosis factor inhibitor failure, and patients 2 years of age or older with active polyarticular course juvenile idiopathic arthritis.

Write to Robb M. Stewart at [e-mail]

(END) Dow Jones Newswires

April 07, 2021 07:26 ET (11:26 GMT)

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