“Long-awaited option”: FDA approves Aimmune’s peanut allergen treatment

03 Feb 2020 --- Biopharmaceutical company Aimmune Therapeutics has received US Food and Drug Administration (FDA) approval for Palforzia, the first approved oral immunotherapy treatment for patients with peanut allergies. Treatment with Palforzia involves administering small amounts of peanuts to increase tolerance to the legume, which can help reduce the severity of allergic reactions such as anaphylaxis. Initial dose escalation can be administered to patients aged four through 17 years and may be continued in individuals four years of age and older – crucial, as both peanut allergy cases in children and their awareness have risen in the past decade.

“Peanut allergy is more common now than ever before and has become a serious public health concern. The food allergy community has been eagerly awaiting an FDA-approved treatment that can help mitigate allergic reactions to peanuts. As allergists, we want nothing more than to have a treatment option to offer our patients that has demonstrated both the safety and efficacy to truly impact the lives of patients who live with peanut allergy,” says Dr. Christina Ciaccio, Associate Professor of Pediatrics and Medicine at the University of Chicago Medical Center and Biological Sciences.

“Not only is Palforzia the first approved therapy for peanut allergy, but it is the first approved therapy for any food allergy,” underscores Dr. Daniel Adelman, Chief Medical Officer of Aimmune Therapeutics.

The Palforiza capsules may help people to desensitize to their peanut allergies over time.Palforzia is a powder that is manufactured from peanuts. Patients can empty the powder from its packaged capsules or sachets and mix it with a small amount of semi-solid food, such as applesauce, yogurt or pudding, which the patient then consumes. The patients are thus desensitized by gradually increasing the doses of peanut flour over time.

Besides the FDA approval, Aimmune is set to provide resources to patients and families – upon consultation with their physician – who wish to seek treatment with Palforzia. These resources will include educational materials, a dedicated call center, a co-pay program for eligible patients and a Patient Assistance Program to provide Palforzia at no cost to eligible patients.

Clinical backing
In a first study testing efficacy, approximately 500 peanut-allergic individuals study participants tolerated a single 600 mg dose of peanut protein (twice the daily maintenance dose of Palforzia) with no more than mild allergic symptoms after six months of maintenance treatment. The results showed that 67 percent of Palforzia recipients tolerated a 600 mg dose of peanut protein in the challenge, compared to 4 percent of placebo recipients. 

The company also assessed the safety of Palforzia in two double-blind, placebo-controlled studies in approximately 700 peanut-allergic individuals. The most commonly reported side effects of Palforzia were abdominal pain, vomiting, nausea, tingling in the mouth, itching in the mouth and ears, coughing, runny nose, throat irritation and tightness, hives, wheezing and shortness of breath and anaphylaxis, a life-threatening whole-body response to an allergen, following accidental exposure to peanuts. The FDA warns against administering Palforzia to those with uncontrolled asthma.

Peanut prevention may no longer be the sole option for people with peanut allergy.To mitigate the risk of anaphylaxis associated with Palforzia, the FDA requires a Risk Evaluation and Mitigation Strategy (REMS) with this approval, which includes elements to assure safe use. 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 FDA also requires healthcare providers who prescribe Palforzia – and healthcare settings that dispense and administer Palforzia – are educated on the risk of anaphylaxis associated with its use.

No cure? Prevention necessity spotlighted
Given there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions. Even with strict avoidance, inadvertent exposures can and do occur, says Dr. Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research. 

“Peanut allergies affect approximately one million children in the US alone. However, only one out of five of these children will outgrow their allergy. 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,” Dr. Marks continues.

“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. The risk of accidental exposure is real and we have long awaited an option beyond avoiding peanuts alone,” concludes Lisa Gable, Chief Executive Officer, Food Allergy Research and Education (FARE). 

Last month, a study revealed that early introduction to allergenic foods, such as eggs and peanuts, could be effective in preventing the development of food allergies in some infants. However, these potential ways to fight peanut allergies come as sesame allergies are becoming increasingly common among children. Additionally, the rise of social media can have both a helpful and harmful effect of spreading allergy information to consumers.

Edited by Anni Schleicher