Aimmune wins FDA approval for first peanut allergy treatment

For the millions of people with peanut allergies, there is a new, one-of-a-kind treatment. Friday, the US Food and Drug Administration (FDA) approved Aimmune Therapeutics’ AR101 oral immunotherapy, which will be marketed under the Palforzia brand.

Palforzia has been approved under an expedited review for use in pediatric patients, ages 4 to 17, who have been diagnosed with a peanut allergy, which can be life-threatening due to potential anaphylaxis. The approval marks a first for those battling peanut allergies. Prior to its full approval, Palforzia was massively supported by the Allergen Product Advisory Committee, which reviewed the data. The committee backed the drug’s approval by a vote of 7 to 2 in favor of efficacy and 8 to 1 for safety.

Shares of Aimmune rose more than 16% in premarket trading today to hit $36.04.

Palforzie [Peanut (Arachis hypogaea) Allergen Powder-dnfp] is an oral treatment indicated to reduce allergic reactions to peanuts. As an oral immunotherapy, specific allergen proteins are ingested initially in very small amounts, followed by gradually increasing amounts, which helps to lessen allergic reactions to the allergen over time. The drug is intended for use with a diet that recommends avoiding peanuts. It is not approved for the emergency treatment of allergic reactions, including anaphylaxis, which means patients with a confirmed peanut allergy may still need their emergency treatments, such as the injector Epi-Pen Auto.

Jayson Dallas, president and CEO of Aimmune Therapeutics, said Palforzia’s approval is a “watershed moment” for people with peanut allergies, as well as the company itself. He said it was exciting to become the first company to offer an FDA-approved treatment for peanut allergy. The list price for the treatment was set at $890 per month or $11,000 per year.

“Our commercial team in the field is ready to start engaging with allergists to help them prepare to safely integrate Palforzia into their practices and, with approval in hand, our payer team can also begin work immediately. to secure access to the Palforzia form. We view this approval as a start for Aimmune, and it underscores our continued commitment to bringing innovative treatments to people with life-threatening food allergies,” Dallas said in a statement.

Daniel Adelman, Aimmune’s chief medical officer, said Palforzia is the first approved treatment for any food allergy in the United States.

Phase III data showed that Aimmune peanut allergy treatment was effective in more than 67% of juvenile patients. Aimmune said 67.2% of miners aged four to 17 who received AR101 in the Palisade trial could tolerate exposure to at least a 600mg dose of peanut protein during the food challenge. Release. Only 4% of placebo patients could tolerate this amount, the company said when announcing the data. It was this data that supported Aimmune’s biologics license application. The FDA is expected to make a decision on Palforzia in early 2020. In June 2015, Aimmune won Breakthrough Therapy Designation Status of the US Food and Drug Administration (FDA) for Palforzia.

It is estimated that there are over 1.6 million children and adolescents in the United States who have some kind of peanut allergy. Palforzia will only be available to patients under a Risk Assessment and Mitigation Strategy (REMS). REMS requirements include: the prescribing physician and patient must be enrolled in REMS prior to the start of treatment; the initial dose escalation and the first dose of each dosage level should be administered in a certified healthcare facility; epinephrine should always be readily available to patients, and pharmacies/dispensers should be certified with REMS.

Aimmune’s Palforzia may not be the only company with an approved peanut allergy treatment. In August, the French company DBV Technologies resubmitted a biologics license application to the FDA for its Viaskin Peanut treatment, its non-invasive anti-allergy patch. The company anticipates regulatory agency action regarding the resubmitted BLA in August 2020.

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