February 3, 2020

First-ever peanut allergy treatment approved by FDA

Federal regulators have approved the first-ever peanut allergy treatment in a development called "a defining moment for the peanut allergy community." 

James R. Baker Jr., MD., director of the Mary H. Weiser Food Allergy Center at the University of Michigan, said he expects the treatment to be offered to qualifying patients at U-M. 

Palforzia, a desensitization treatment intended for children and teens from age 4-17, was approved at the end of January by the U.S. Food and Drug Administration.  It was developed by Aimmune Therapeutics Inc. of Brisbane, California.

 "Finally, we can offer patients an alternative to the difficult task of absolutely avoiding all peanut,” said Baker.  “While they will still have to carry and use their EpiPen, they should be protected from most life threatening reactions that occur with the accidental ingestions patients most often encounter.”

Palforizia is a complex peanut-based biologic drug used with a structured dosing approach that builds on a century of oral immunotherapy (OIT) research.  With OIT, the specific allergenic proteins are ingested initially in very small quantities, followed by incrementally increasing amounts, resulting in the ability to mitigate allergic reactions to the allergen over time, the company said.  Aimmune officials said they will begin working immediately with clinicians and insurers to extend the therapy to patients.

Baker, who serves as a consultant to Aimmune and testified in favor of Palforizia during the FDA evaluation, said he expects that the U-M allergy clinic may begin offering the treatment to patients within about three months.

Patients and doctors at U-M participated in the clinical trial that led to the drug’s approval.  Baker said subjects taking the oral medication built up tolerance over a 28-week period.  After that, they take a maintenance dose indefinitely; it’s too soon to tell if patients eventually will be able to stop taking Palforzia yet maintain the protection from severe allergic reactions.

 Not all patients will tolerate the desensitization therapy, Baker said, which suggests that peanut allergy may have more than one cause.  “We will need multiple treatment options to help all patients,” he said.

 Aimmune said it intends to press forward with the development of other therapies for food allergy.

"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," the company said in a press release.

The industry publication Allergic Living reported that the treatment is expected to cost $890 per month, with some financial assistance available to patients who qualify. 

Read the Aimmune press release here.