Aimmune Therapeutics Inc (NASDAQ:AIMT) leaped on Monday morning, on a positive Food and Drug Adminisration verdict for Aimunne's peanut allergy drug. The FDA approved Palforzia allergen powder for treating patients with confirmed diagnosis of peanut allergy.
The Brisbane, Calif.-based drug company said Palforzia is the first approved treatment for patients with peanut allergy. It is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, which may occur with accidental exposure to peanut.
Palforzia 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. Palforzia is not indicated for the emergency treatment of allergic reactions, including anaphylaxis.
Said CEO Jayson Dallas, "Our commercial field team is ready to begin engaging with allergists to help them prepare to safely incorporate Palforzia into their practices and, with approval in hand, our payer team can also immediately begin work to secure formulary access to Palforzia.
"We view this approval as just the beginning for Aimmune, and it underscores our continued commitment to bringing innovative treatments to people with potentially life-threatening food allergies."
Peanut allergy is one of the most common food allergies in the world, affecting more than 1.6 million children and teens in the United States alone. It can be a chronic and life-long condition, and reactions to peanut can range from mild to potentially life-threatening with one in five peanut-allergic patients visiting emergency rooms each year due to accidental exposure.
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