FDA clears landmark peanut allergy drug Palforzia

There is a potentially lucrative market for peanut allergy medications-including a landmark medication approved by FDA last week.

FDA cleared Aimmune Therapeutics’ Peanut (Arachis hypogaea) Allergen Powder-dnfp (Palforzia) to mitigate anaphylaxis and other allergic reactions that may occur from accidental exposure to peanuts.

Palforzia is the first oral immunotherapy to reduce allergic reactions from exposure to peanuts, wrote Sumit Dutta, chief medical officer at OptumRx in the PBM’s new report, Q1 2020 Drug Pipeline Insights Report.

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The medication is ingested to gradually increase doses of purified peanut protein in order to help the immune system learn to tolerate peanuts, Dutta says.

“This practice of oral immunotherapy is being offered today by some allergists but has yet been available as an FDA-approved drug,” he adds.

Peanut allergy remains the most common food allergy in the U.S. since between 6 and 15 million children experience allergic symptoms when exposed to peanuts, Dutta wrote.

“Because of the large patient population, and minimal treatment options, there is a $4.5 billion global market for drug manufacturers to treat peanut allergies,” he says. 

“Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions,” says Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a statement from FDA. “Even with strict avoidance, inadvertent exposures can and do occur. When used in conjunction with peanut avoidance, Palforzia provides an FDA-approved treatment option to help reduce the risk of these allergic reactions in children with peanut allergy.”

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Children 4 through 17 years with a confirmed diagnosis of peanut allergy can take Palforzia, according to the FDA. However, those taking the medication must continue to avoid peanuts in their diets. 

To mitigate the risk of anaphylaxis associated with Palforzia, FDA is requiring a Risk Evaluation and Mitigation Strategy (REMS) with the approval.

Palforzia will only be available through specially certified healthcare providers, health care settings, and pharmacies to patients who are enrolled in the REMS program.

The effectiveness of Palforzia is supported by a randomized, double-blind, placebo-controlled study conducted in the U.S., Canada, and Europe in approximately 500 peanut-allergic individuals. Around 67% of Palforzia recipients tolerated a 600 mg. dose of peanut protein in the challenge, compared to 4% of placebo recipients. 

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