An advisory committee of the FDA voted to support the use of Aimmune Therapeutics’ (NASDAQ:AIMT) PALFORZIA in children and teens with peanut allergy.
The committee voted seven-to-two that the efficacy data and eight-to-one that the safety data, in conjunction with additional safeguards, are adequate to support the use of PALFORZIA. Aimmune’s BLA for PALFORZIA is under review by the FDA, with a review action due date of late January 2020.
The European Medicines Agency also is reviewing Aimmune’s marketing authorization application for PALFORZIA, which the company submitted in June 2019.
In a statement, Dr. Jayson Dallas, president and CEO of Aimmune, said patient safety has been central to the company since the beginning of the PALFORZIA development program. “We look forward to working with the agency to finalize our proposals, which we believe will support the safe and appropriate use of PALFORZIA.”
The BLA includes extensive clinical data from the largest and only Phase 3 clinical trials to meet primary endpoints in children and teens with peanut allergy, with more than 1,000 patients enrolled.
The results demonstrated that PALFORZIA treatment resulted in a significant increase in the amount of peanut protein tolerated, treated patients could expect fewer and less severe reactions to accidental peanut exposures, and PALFORZIA significantly reduced the incidence and severity of allergic reactions, including anaphylaxis, after accidental exposure to peanut.