Final European Commission decision on marketing approval anticipated in Q4 2020
Aimmune Therapeutics, a Nestlé Health Science Company, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion on PALFORZIA [defatted powder of Arachis hypogaea L., semen (peanuts)] for the treatment of peanut allergy in peanut allergic patients aged 4–17 years in the European Union.
The CHMP opinion follows the January 2020 US Food and Drug Administration (FDA) approval of PALFORZIA as an oral immunotherapy for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut in patients aged 4 through 17 years with a confirmed diagnosis of peanut allergy.
"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 Therapeutics.
"Today’s decision underscores the strong and compelling data from our PALFORZIA clinical trials and follows the U.S. 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 positive opinion is based on the Company’s regulatory submission supported by a comprehensive data package, including efficacy and safety results from the Phase III ARTEMIS trial, which included 175 peanut-allergic patients aged 4 to 17 years enrolled at 18 sites in seven European countries.
ARTEMIS met all primary, secondary and safety endpoints, and demonstrated that patients treated with PALFORZIA experienced a high degree of desensitisation to peanut with an anticipated and manageable safety profile.
The EMA is an agency of the European Union responsible for the scientific evaluation of medicines submitted for approval by pharmaceutical companies for use in the 28 countries of the European Union.
The positive CHMP opinion will be reviewed by the European Commission, and a final decision on PALFORZIA to treat peanut allergy is anticipated in the fourth quarter of 2020.
PALFORZIA (formerly known as AR101) was approved by the US Food and Drug Administration (FDA) in January 2020 as an oral immunotherapy for the mitigation of allergic reactions, including anaphylaxis, that can occur with accidental exposure to peanut in patients aged 4 through 17 years with a confirmed diagnosis of peanut allergy.
A Swiss Agency for Therapeutic Products (SwissMedic) review of AR101 also is ongoing.