Aimmune has been granted a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for its drug Palforzia as a treatment of peanut allergic patients aged 4-17 years.
The CHMP’s positive opinion on Palforzia is based on a comprehensive data package which includes efficacy and safety data from the phase III ARTEMIS trial.
This trial tested Palforzia in 175 peanut-allergic patients aged 4-17 years enrolled across 18 sites in seven European countries. Palforzia met all primary, secondary and safety endpoints in the ARTEMIS trial and the patients treated with Aimmune’s drug experienced a high degree of desensitisation coupled with a manageable safety profile.
“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,” said Andrew Oxtoby, president and chief executive officer of Aimmune.
“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,” he added.
In January, the US Food and Drug Administration (FDA) approved Palforzia as an oral immunotherapy for the mitigation of allergic reactions that may occur with accidental exposure to peanuts in patients aged 4-17 years with a confirmed peanut allergy.
Following the positive CHMP opinion, Aimmune said that the European Commission will review the committee’s recommendation with a final decision on Palforzia expected in the fourth quarter of 2020.