The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for AR101 (Aimmune Therapeutics) to reduce the risk of anaphylaxis following accidental exposure to peanut.
The BLA submission contains data from two phase 3 trials: PALISADE and RAMSES. In PALISADE, treatment with AR101 resulted in a significant increase in the amount of peanut protein that could be ingested by children and adolescents with peanut allergy, compared with placebo. The safety profile of AR101 was further confirmed in the RAMSES study, which included 506 peanut-allergic children and teens.
“We are working with the FDA to complete their review as expeditiously as possible given that there are currently no approved medicines for peanut allergy,” said Jayson Dallas MD, President and CEO of Aimmune.
The BLA will be reviewed under a 12-month target review period which will run though late January 2020.
For more information visit Aimmune.com.