Shares of biopharma Aimmune Therapeutics Inc (NASDAQ: AIMT) advanced strongly in after-hours trading Friday following a positive FDA verdict for Aimunne's peanut allergy drug.
9-Year Wait Ends
The FDA approved Palforzia allergen powder for treating patients with confirmed diagnosis of peanut allergy, the Brisbane, California-based company said in a late Friday release.
This is the first commercial success for the company, which was founded in 2011 and is working exclusively on therapies for food allergies.
An FDA panel, which reviewed the BLA for Palforzia back in September, voted 7-2, recommending the approval on the grounds of efficacy and safety.
Palforzia is an oral immunotherapy meant to mitigate allergic reactions, including anaphylaxis that may occur with accidental exposure to peanut.
The mechanism of action goes like this: the allergenic proteins are taken initially in small quantities, following by increasing amounts of ingestion, which helps mitigation of allergic reactions to the allergen over time.
Initial dose escalation may be administered to patients ages 4-17, and the updosing and maintenance could be continued in patients 4 and older, Aimmune said.
“This is a defining moment for the peanut …
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