Aimmune receives positive CHMP opinion on Palforzia for the treatment of peanut allergy in Europe.

Aimmune Therapeutics, Inc., a Nestlé Health Science Company, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion on Palforzia [defatted powder of Arachis hypogaea L., semen (peanuts)] for the treatment of peanut allergy in peanut allergic patients aged 4 – 17 years in the European Union. The CHMP opinion follows the January 2020 FDA approval of Palforzia as an oral immunotherapy for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut in patients aged 4 through 17 years with a confirmed diagnosis of peanut allergy. The positive opinion is based on the Company’s regulatory submission supported by a comprehensive data package, including efficacy and safety results from the Phase III ARTEMIS trial, which included 175 peanut-allergic patients aged 4 to 17 years enrolled at 18 sites in seven European countries. ARTEMIS met all primary, secondary and safety endpoints, and demonstrated that patients treated with Palforzia experienced a high degree of desensitization to peanut with an anticipated and manageable safety profile.