FDA Extends Review Period on Pfizer Drug Applications for Abrocitinib, Xeljanz/Xeljanz XR
April 07 2021 - 7:41AM
Dow Jones News
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 robb.stewart@wsj.com
(END) Dow Jones Newswires
April 07, 2021 07:26 ET (11:26 GMT)
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