FDA approves first ever treatment for peanut allergy

On Friday, the US Food and Drug Administration approved Palforzia (Peanut [Arachis hypogaea] allergen powder-dnfp) as the first ever treatment for patients with peanut allergy, with the news sending the shares of the product’s developer, Aimmune Therapeutics (Nasdaq: AIMT), rocketing 16.55% to $36.19 in after-hours trading.

The California-based biotech explained that this is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. Palforzia, previously code-named AR101, is approved for use in patients with a confirmed diagnosis of peanut allergy. Initial dose escalation may be administered to patients aged four through 17 years. Up-dosing and maintenance may be continued in patients four years of age and older. Palforzia is to be used in conjunction with a peanut-avoidant diet. It is not indicated for the emergency treatment of allergic reactions, including anaphylaxis.

Aimmune said the list price for Palforzia will be $890 a month, or about $10,680 a year. Roth Capital Research analyst Zegbeh Jallah estimates the drug could generate annual sales of $1 billion by 2026, and Aimmune’s chief financial officer Eric Bjerkholt has previously projected revenues in excess of $1 billion.