First Drug for Peanut Allergy Receives Approval from US Regulators

The U.S. health agency has approved the first drug for children and adolescents with peanut allergy, which represents a possible paradigm shift in treatment.

The drug, which is sold under the Palforzia brand name, is marketed by Aimmune Therapeutics Inc. Therapy involves taking small doses of peanut protein, which are gradually increased over time to help desensitize patients to a higher level. The drug is similar to oral therapies offered by some allergy sufferers. However, it is the first to be approved by the United States Food and Drug Administration.

The drug, according to Christina Ciaccio, professor of pediatrics at the University of Chicago and investigator for Palforzia in US studies, will be “a pioneer for doctors and patients with food allergy”. “So far, we have only been able to tell patients to carefully monitor what they eat and that if they respond, they must always be prepared with an adrenaline auto-injector.”

The new drug is not a cure for patients, and studies have shown that it may not work for everyone who receives it. However, according to Aimunne, the benefits can be life-changing for parents and children who are concerned about the potentially fatal consequences of accidental exposure.

Palforzia is designed to address patients and allergists who want regulated therapy that is trustworthy and has a consistent protocol, said Chief Executive Officer Jayson Dallas. The approval is “a crucial moment for the entire peanut allergy community” and can “usher in a new era in the treatment of peanut allergies and long term food allergies in general,” Dallas said in a message to Bloomberg News.

Ciaccio of the University of Chicago repeated this assessment, saying that she had already enrolled patients for treatment after approval and even had six months to visit. While the drug “will not be a universal fit for all patients,” she looks forward to the day when there are several treatments offered to patients to decide which is the best fit.

Of the approximately 3 million people in the United States with peanut allergies, around half would reach the target age group of four to 17 years, according to Aimmune. The company, based in Brisbane, California, sees a similar opportunity in Europe.

According to Aimmune, around 1,300 allergy sufferers have been identified  and willing to receive the therapy if it is commercially available. Around 250 of this group already use do-it-yourself oral immunotherapy in their offices. Aimmune set the wholesale cost of acquisition at $ 890 per month, regardless of the patient dosage phase.