Palforzia FDA approval : Aimmune Therapeutics has been granted approval from the US Food and Drug Administration (FDA) for Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] for the treatment of peanut allergy in children.

The peanut allergy drug has been approved for mitigating allergic reactions such as anaphylaxis, that may result from accidental exposure to peanuts, said the FDA.

The US drug regulator said that treatment with Palforzia may be started in individuals ages 4 through 17 years with a confirmed diagnosis of peanut allergy and could be continued in 4 years of age and older.

The FDA cautioned that people taking Palforzia must continue to avoid peanuts in their diets.

Commenting on Palforzia FDA approval, Peter Marks – director of the FDA Center for Biologics Evaluation and Research, said: “Peanut allergy affects approximately 1 million children in the U.S. and only 1 out of 5 of these children will outgrow their allergy. Because 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. 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.”

According to the FDA, while antihistamines and epinephrine can be used for treating allergic reactions, severe reactions from exposure to peanuts can be fatal even with appropriate, prompt treatment. The drug regulatory body said that Palforzia cannot be used for the emergency treatment of anaphylaxis and other allergic reactions.

The FDA described Palforzia as a powder made from peanuts and packaged in pull-apart color-coded capsules for Dose Escalation and Up-Dosing, and in a sachet for providing maintenance treatment. The powder has to be emptied from the capsules or sachet and mixed with a small amount of semisolid food like yogurt, applesauce, or pudding for consumption.

Palforzia FDA approval is based on a randomized, double-blind, placebo-controlled trial held in the US, Canada, and Europe in nearly 500 peanut-allergic individuals.

Effectiveness of the peanut allergy drug was studied by evaluating the percentage of study participants tolerating an oral challenge with a single 600mg dose of peanut protein (two times the daily maintenance dose of Palforzia) with no more than mild allergic symptoms following six months of maintenance treatment.

Results from the study proved that 67.2% of recipients of Palforzia tolerated a 600mg dose of peanut protein in the challenge in comparison to 4.0% of placebo recipients, said the FDA.

On the other hand, the safety of Palforzia was evaluated in a couple of double-blind, placebo-controlled studies in nearly 700 individuals with peanut allergy. The most commonly reported side effects of the new peanut allergy drug were abdominal pain, vomiting, nausea, throat irritation and tightness, tingling in the mouth, itching, cough, runny nose, hives, wheezing and shortness of breath and anaphylaxis.

The FDA said that Palforzia should not be given to those with uncontrolled asthma.

To mitigate the risk of anaphylaxis related to Palforzia, the FDA needs a Risk Evaluation and Mitigation Strategy (REMS) with the approval, which includes elements to ensure safe use. Palforzia will only be available via specially certified healthcare providers, pharmacies, and health care settings to patients enrolled in the REMS program, said the FDA.

Jayson Dallas – President and CEO of Aimmune Therapeutics, commenting on Palforzia FDA approval, said: “This is a defining moment for the peanut allergy community and for Aimmune Therapeutics, and we are excited to bring the first FDA-approved treatment for peanut allergy to patients and their families.

“Our commercial field team is ready to begin engaging with allergists to help them prepare to safely incorporate PALFORZIA into their practices and, with approval in hand, our payer team can also immediately begin work to secure formulary access to PALFORZIA. 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.”

  Aimmune Therapeutics, FDA, Jayson Dallas, Palforzia, Peter Marks, US Food and Drug Administration, USA