The US Food and Drug Administration approved a drug to treat life-threatening allergic reactions for the approximately 1 million children in the US with peanut allergies. The drug, Palforzia, will list for $890 a month and brings its own risks, the Wall Street Journal reports.
Peanut allergies are one of the most common among American children, and can trigger a wide variety of reactions, including runny nose, stomach cramping, indigestion, hives, swelling, fainting, and anaphylaxis. Though that will continue to be necessary with Palforzia, the risk of a reaction will be lessened, says Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, in a statement. Though patients will still be encouraged to avoid any exposure to peanuts, the drug will be an added measure to help children in the case of accidental contact with peanuts.
The FDA noted that Palforzia is not to be used for emergency treatment for allergic reaction like anaphylaxis. It's not clear how long patients would have to take Palforzia, per the Washington Post.
Treatment with this oral immunotherapy may be initiated in individuals ages 4 years to 17 years with a confirmed diagnosis of peanut allergy, and may be continued in individuals 4 years of age and older.
Peanuts are the most common food allergen in the U.S., with an increase in the number of those affected by food allergies across the West in recent decades. Palforzia can not be used for the emergency treatment of allergic reactions, including anaphylaxis.
The first phase, Initial Dose Escalation, happens on a single day.
"Peanut allergy carries an overwhelming psychosocial burden that impacts patients and their families daily - peanuts are everywhere, and the threat of a severe reaction related to an accidental peanut exposure dominates families' daily lives", said Lisa Gable, Chief Executive Officer of the Food Allergy Research and Education (FARE), in Aimmune's press release.
Palforzia comes in a powder form that is made from actual peanuts, and should be mixed with semi-solid food like yogurt or applesauce.
At the start of the study, the equivalent of one-third of a peanut kernel triggered an allergic reaction in Noah.
The drug AR101, or Palforzia, uses oral immunotherapy, with children given tiny but increasing amounts of peanut protein over a six-month period under medical supervision.
Safety testing: Two double-blind, placebo-controlled studies700 people with peanut allergies in.
The results showed that 67.2% of Palforzia recipients tolerated a 600 mg dose of peanut protein in the challenge, compared to 4.0% of placebo recipients.
So the FDA says patients and doctors must enroll in a safety program and that each dose increase is given in a certified health facility.