The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) recommended on October 15 that marketing authorization be granted for Palforzia (Aimmune Therapeutics). The product is intended for desensitizing children and adolescents to peanut allergy.
Palforzia will be available as an oral powder in capsules (0.5, 1, 10, 20, and 100 mg) and as oral powder in sachet (300 mg). The active substance is defatted powder of Arachis hypogaea.
Through use of the product, children with a peanut allergy receive controlled exposure to precise, increasing amounts of peanut protein, mixed with soft food, every day. Over time, this may help to decrease their sensitivity to small amounts of peanuts.
According to the press release from the EMA, Palforzia can mitigate accidental exposure to small amounts of peanut protein. “[A] single dose of a least 1 gram of peanut protein would cause no more than mild allergy symptoms,” the EMA said.
The treatment is indicated for patients aged 4 to 17 years who have received a confirmed diagnosis of peanut allergy. Treatment may be continued for patients aged 18 years or older, according to the press release.
It should be administered under the supervision of a healthcare provider qualified in the diagnosis and treatment of allergic diseases and should be used in conjunction with a peanut-avoidant diet, the EMA notes.
The most common side effects that have been reported are abdominal pain, throat irritation, itch, nausea, vomiting, urticaria, and upper abdominal discomfort.
The next step in the approval process is to obtain market authorization from the European Commission. Detailed recommendations for use will be described in the summary of product characteristics, which will be published in the European public assessment report and will be made available throughout Europe.
“We are encouraged by the CHMP opinion, which recommends Palforzia as the first and only treatment option in the European Union for patients with peanut allergy and their families,” Andrew Oxtoby, president and chief executive officer of Aimmune Therapeutics, said in a statement. “Today’s decision underscores the strong and compelling data from our Palforzia clinical trials and follows the US FDA approval of Palforzia earlier this year. We look forward to the European Commission’s final decision for the marketing approval of Palforzia, which we expect later this year.”
The FDA said in granting its approval that patients, parents, or caregivers must be counseled on the need for always-available injectable epinephrine, the need for continued peanut avoidance, and on how to recognize signs of anaphylaxis.
Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune and Nurse.com and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick.