FDA advisory panel supports first peanut allergy treatment, Aimmune's Palforzia
A US Food and Drug Administration advisory panel on Friday voted in favor of recommending approval of the first peanut allergy treatment, sending shares of the drug’s developer, US biotech firm Aimmune Therapeutics’ (Nasdaq: AIMT), shooting up 16.7% to $28.80 in after-hours trading.
The Allergenic Products Advisory Committee (APAC) convened by the FDA voted to support the use of AR101 (proposed trade name Palforzia) in children and teens with peanut allergy.
The APAC voted 7 to 2 that the efficacy data and 8 to 1 that the safety data, in conjunction with additional safeguards, are adequate to support the use of Palforzia, a peanut-derived, biologic drug candidate.
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