Pfizer Study of Abrocitinib Vs Dupixent Meets Main Endpoints
30 August 2021 - 01:58PM
Dow Jones News
By Colin Kellaher
Pfizer Inc. on Monday reported positive results from a Phase 3
study comparing its proposed atopic-dermatitis drug abrocitinib to
Dupixent, the blockbuster treatment from Regeneron Pharmaceuticals
Inc. and Sanofi SA.
Pfizer said the study, which met its co-primary and key
secondary efficacy endpoints, showed that abrocitinib was
statistically superior compared with Dupixent in each evaluated
efficacy measure and had a safety profile consistent with previous
studies.
The New York drugmaker said it plans to share the study data
with the U.S. Food and Drug Administration and other regulatory
agencies that are reviewing abrocitinib for the chronic skin
disease.
Late last year, the FDA granted priority review to Pfizer's new
drug application for abrocitinib, with a decision expected in April
2021. However, the agency later extended its review by three months
to July, then last month said it wouldn't meet the new target
action date as it looks into the safety of JAK inhibitor drugs.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
August 30, 2021 07:43 ET (11:43 GMT)
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