FDA Approves First-Ever Peanut Allergy Treatment
Aimmune Therapeutics Inc. (NASDAQ: AIMT) shares jumped early on Monday after the U.S. Food and Drug Administration (FDA) announced late Friday a critical approval for the firm’s peanut allergy treatment.
Specifically, the FDA approved Palforzia for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts.
It’s worth pointing out that Palforzia is not only the first approved therapy for peanut allergy, but also it is the first approved therapy for any food allergy.
Some quick background: 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 exposures.
Jayson Dallas, M.D., president and CEO of Aimmune Therapeutics, commented:
This is a defining moment for the peanut allergy community and for Aimmune Therapeutics, and we are excited to bring the first FDA-approved treatment for peanut allergy to patients and their families. 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.
Shares of Aimmune Therapeutics traded up 7.5% early Monday at $33.39, in a 52-week range of $16.95 to $37.00. The consensus analyst price target is $47.82.