FDA approves first treatment for peanut allergy
Aimmune Therapeutics's Palforzia can now be used to treat patients aged 4 through 17 years.
Daniel Adelman, chief medical officer of Aimmune, said, "Not only is Palforzia the first approved therapy for peanut allergy, but it is the first approved therapy for any food allergy."
The Palforzia drug reportedly will list for $890 a month.
Peanut allergy, which is one of the most common food allergies in the world, affects more than 1.6 million children and teens in the United States.
In a statement, the biopharmaceutical company developing solutions to treat food allergies said the new drug is an oral immunotherapy or OIT indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental peanut exposure.
With OIT, the specific allergenic proteins are ingested initially in very small quantities, followed by incrementally increasing amounts. This results in the ability to mitigate allergic reactions to the allergen over time. The new drug's doses contain the equivalent of small amounts of peanuts.
The company said the Initial Dose Escalation may be administered to patients aged 4 through 17 years. Up dosing and maintenance may be continued in patients 4 years of age and older, and the drug is to be used in conjunction with a peanut avoidant diet.
Palforzia is approved for use in patients with a confirmed diagnosis of peanut allergy, while it is not indicated for the emergency treatment of allergic reactions, including anaphylaxis.
The company also warned that the new drug can cause life threatening anaphylaxis. Due to this, the drug will be available only through a restricted program under a Risk Evaluation and Mitigation Strategy or REMS called the PALFORZIA REMS. ■