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# Pfizer NDA for Alopecia Drug Accepted for Review
- URL: https://www.fdaweb.com/pfizer-nda-for-alopecia-drug-accepted-for-review/
- Published: 2022-09-09T12:00:00.000Z
- Updated: 2026-09-14T17:58:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152702

FDA has accepted for review a Pfizer NDA for baldness drug ritlecitinib for treating adults and adolescents 12 years of age and older with alopecia areata. The agency is expected to make a decision in the second-quarter next year.

Pfizer says the submission was based on [previously announced topline results](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.pfizer.com%2Fnews%2Fpress-release%2Fpress-release-detail%2Fpfizer-announces-positive-top-line-results-phase-2b3-trial&esheet=52879165&newsitemid=20220908006121&lan=en-US&anchor=previously+announced+topline+results&index=2&md5=abebdeb27028fa19ba5a4bf9949063b6&ref=fdaweb.com) from the pivotal and dose-ranging Phase 2b/3 ALLEGRO study. Data showed a statistically significantly higher proportion of patients treated with ritlecitinib 30 mg and 50 mg had 80% or more scalp hair coverage after six months compared with placebo, it says. The most common adverse events reported were headache, nasopharyngitis, and upper respiratory tract infections.