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# Aimmune BLA for Peanut Allergy Under Review
- URL: https://www.fdaweb.com/aimmune-bla-for-peanut-allergy-under-review/
- Published: 2019-03-18T12:00:00.000Z
- Updated: 2026-09-15T01:13:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143629

FDA has accepted for review an Aimmune Therapeutics BLA for AR101 as a treatment to reduce the risk of anaphylaxis following accidental exposure to peanuts. The agency has set a 12-month review deadline to be completed 1/2020\. The company says it has been told that FDA expects to convene an advisory committee meeting to discuss the application.

The submission is based on data from the pivotal phase 3 PALISADE trial, which the company says demonstrated that AR101 treatment resulted in a significant increase in the amount of peanut protein tolerated compared to placebo. “The data suggest that AR101-treated patients could expect fewer and less severe reactions to accidental peanut exposures,” Aimmune says.