Aimmune Therapeutics, which was recently acquired by Nestlé in a $2.6-billion deal, on Friday announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Palforzia (peanut allergen powder-dnfp) to treat peanut allergy in young people aged four to 17 years. The CHMP backing follows US approval of the oral immunotherapy in January as a treatment to mitigate allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts.
A final decision on Palforzia by European regulators is anticipated in the fourth quarter. Andrew Oxtoby, chief executive at Aimmune, said that if approved, Palforzia would be the "first and only treatment option" in the EU for patients with peanut allergy.
The positive opinion is supported by results from the Phase III ARTEMIS trial, which included 175 peanut-allergic patients aged four to 17 years enrolled across several European countries. Results from the study showed that it met all primary, secondary and safety endpoints, and demonstrated that treatment with Palforzia, also known as AR101, led to a "high degree of desensitisation to peanut with an increasingly well-understood, anticipated, and manageable safety profile over nine months," the company said. Full results were published in The Lancet Child & Adolescent Health journal in July.
Aimmune noted that a review of the treatment by regulators in Switzerland is ongoing.
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