BRIEF—Aimmune submits MAA for peanut allergy drug

American biotech, Aimmune Therapeutics, has announced its submission of a Marketing Authorization Application to the European Medicines Agency for AR101.

The candidate is an investigational biologic oral immunotherapy to reduce the frequency and severity of allergic reactions following exposure to peanuts in children and adolescents aged four to 17.

Aimmune’s application includes data from a Phase III clinical trial program.

A Biologics License Application (BLA) seeking approval for AR101 is currently being reviewed by the US Food and Drug Administration (FDA), with a decision expected by late January 2020.

The Allergenic Products Advisory Committee of the FDA will review the BLA for AR101 at its meeting scheduled for September 13, 2019.