FDA Grants Peanut Allergy Drug Breakthrough Status
Aimmune Therapeutics has won FDA breakthrough therapy designation for AR101, an oral immunotherapy for children and adolescents with peanut allergies.
The designation, which entitles the company to more frequent meetings with the FDA on its drug development plan and rolling review, follows FDA fast-track designation last September.
AR101 combines naturally occurring and pharmaceutical-grade inactive ingredients designed to enable dosing of peanut protein with peanut allergen concentrations. Patients ingest AR101 with food, over time developing desensitization to peanuts, the company says.
In a Phase 2 trial, 100 percent of patients undergoing treatment with AR101 were able to tolerate a cumulative amount of 443 mg of peanut protein and 78 percent were able to tolerate 1,043 mg of peanut protein. The company plans a Phase 3 trial with adults as well as children and adolescents.
This isn’t the first time the FDA has granted breakthrough therapy designation for a peanut allergy treatment. In April, the agency awarded the designation to France-based DBV Technologies for its Viaskin Peanut, an electrostatic patch that delivers immunotherapy through the skin.
Peanut allergies rose by an estimated 10 percent annually from 1997 to 2008, according to the National Institute of Allergy and Infectious Diseases. — Jason Scott