FDA Extends New Drug Application Of Pfizer's Abrocitinib, XELJANZ

Pfizer Inc. (PFE) said on Wednesday that the U.S. Food and Drug Administration or FDA has notified the company that it will not meet the Prescription Drug User Fee Act or PDUFA goal dates for the New Drug Application submitted by the company for abrocitinib for treating adults and adolescents with moderate to severe atopic dermatitis and the supplemental New Drug Application for XELJANZ/XELJANZ XR (tofacitinib) for treating adults with active ankylosing spondylitis.

According to Pfizer, the FDA has given its ongoing review of the company's post-marketing safety study, ORAL Surveillance, evaluating tofacitinib in rheumatoid arthritis patients, as a reason for the extensions.

Commenting on the developments, Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development, said, "We remain confident in the benefit-risk profiles of abrocitinib and XELJANZ, both of which have been demonstrated in robust clinical trial programs. For people who are suffering with moderate to severe atopic dermatitis or active ankylosing spondylitis, many have limited treatment options."

Earlier, the FDA had extended the PDUFA goal dates to the early third quarter of this year.

Pfizer said that Abrocitinib is an oral small molecule that selectively inhibits Janus kinase (JAK) 1, which will stimulate multiple cytokines involved in the pathophysiology of atopic dermatitis, including interleukin IL-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP).

XELJANZ or tofacitinib has got approval in the U.S. for four conditions. These include 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. The drug has been a part of more than 50 trials on a worldwide basis.

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