Aimmune Therapeutics said that the first patients in the US are being treated with the recently FDA approved peanut allergy drug PALFORZIA [Peanut (Arachis hypogaea) Allergen Powder-dnfp].
The California-based biopharma company said that specialty pharmacies are shipping initial dosing kits of the new peanut allergy drug to allergists for in-office administration to their peanut-allergic patients aged between four and 17 years who have a confirmed diagnosis of peanut allergy.
Jayson Dallas – President and CEO of Aimmune Therapeutics said: “We are pleased that peanut-allergic children are being treated with PALFORZIA just six weeks after its FDA approval. Our anticipation of and preparedness for the REMS program allowed for a swift and smooth implementation of those requirements. In addition, our U.S.-based supply chain remains fully operational and commercial supply is available.
“Since our REMS website went live on February 21, well over 600 allergists are certified and ready to prescribe PALFORZIA to their patients. Our field team is continuing to meet with allergists to provide direction and information on the REMS process to help additional physicians and practices become certified and provide training on how to safely incorporate PALFORZIA into their practices.”
The new peanut allergy drug may be administered to patients only by allergists and allergy practices that have been certified under the Risk Evaluation and Mitigation Strategy (REMS) program, said Aimmune Therapeutics, which recently secured an additional equity investment of $200 million from Nestlé Health Science.
PALFORZIA was approved in late January by the US Food and Drug Administration (FDA) as an oral immunotherapy for the mitigation of allergic reactions, including anaphylaxis, that may result from accidental exposure to peanut.
Read about PALFORZIA FDA approval here.