Pfizer Study of Abrocitinib Vs Dupixent Meets Main Endpoints

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 [e-mail]

(END) Dow Jones Newswires

August 30, 2021 07:43 ET (11:43 GMT)

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