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Aimmune’s Palforzia Gains US FDA Panel Nod But Faces REMS Restrictions

 
• By Sue Sutter

The agency’s plan to require a Risk Evaluation and Mitigation Strategy aimed at systemic allergic reactions with the peanut allergy immunotherapy did not go far enough, advisory committee members said, pushing for additional measures to be folded into the program.

FDA Advisory Committee Feature image
Palforzia garnered favorable AdComm votes on efficacy and safety.

A US Food and Drug Administration panel endorsed the efficacy and safety of Aimmune Therapeutics Inc.'s peanut allergy immunotherapy Palforzia on 13 September but recommended more stringent risk management measures than those proposed by the sponsor or agency.

The majority of the Allergenic Products Advisory Committee said the efficacy data supported the use of Palforzia (peanut, Arachis hypogaea, allergen powder for oral administration) to reduce the incidence and severity of allergic reactions, including anaphylaxis, after accidental

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