Shares in Aimmune Therapeutics gained as much as 15% Friday after the FDA cleared the company's filing for Palforzia (peanut allergen powder-dnfp), also known as AR101, making it the first approved treatment for patients with peanut allergy. The decision follows a 7-2 vote last September by an FDA advisory panel backing approval of the oral immunotherapy to mitigate allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts.
Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, noted that "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." The product is not indicated for the emergency treatment of allergic reactions, including anaphylaxis.
Aimmune, which has set the list price for Palforzia at $890 a month, said it hopes doctors can begin prescribing the treatment in "a matter of weeks." The FDA noted that treatment with Palforzia may be initiated in individuals ages four through 17 years with a confirmed diagnosis of peanut allergy and may be continued in individuals four years of age and older.
According to CEO Jayson Dallas, Aimmune's "commercial field team is ready to begin engaging with allergists to help them prepare to safely incorporate Palforzia into their practices." The executive added that "our payer team can also immediately begin work to secure formulary access to Palforzia."
The FDA approval was supported by data from the pivotal Phase III PALISADE trial, which demonstrated efficacy across the entire intent-to-treat population of peanut-allergic patients ages four to 55 years, and the late-stage RAMSES study. In addition, results from the Phase II ARC001 and ARC002 trials were included in the filing, as well as data from ARC004, ARC008 and ARC011, which are ongoing studies.
However, an FDA staff report released last year pointed to the fact that Palforzia was also associated with higher rates of treatment discontinuation, systemic allergic reactions and eosinophilic esophagitis compared to placebo. On Friday, the FDA said that in order to mitigate the risk of anaphylaxis associated with Palforzia, it is requiring a Risk Evaluation and Mitigation Strategy (REMS) with the approval. Specifically, Palforzia will only be available through specially certified healthcare providers, healthcare settings and pharmacies. In addition, the initial dose-escalation phase and first dose of each "up-dosing" level must only be administered to patients in a certified healthcare setting equipped to monitor patients and to identify and manage anaphylaxis.
The treatment is currently under review by regulators in Europe to reduce the frequency and severity of allergic reactions following exposure to peanuts in children and adolescents ages four to 17.
Last August, DBV Technologies submitted its application to the FDA for the Viaskin Peanut patch for peanut-allergic children ages four to 11 years, with a decision expected by August this year.
To read more Top Story articles, click here.