LONDON - Aimmune Therapeutics, Inc., a Nestle Health Science Company, today 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 U.S. 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 3 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 desensitization 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 U.S. 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.
Aimmune Therapeutics, Inc., a Nestle Health Science Company, is a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies. With a mission to improve the lives of people with food allergies, Aimmune is developing and commercializing oral treatments for potentially life-threatening food allergies. The Company's Characterized Oral Desensitization ImmunoTherapy (CODIT) approach is intended to provide meaningful levels of protection against allergic reactions resulting from accidental exposure to food allergens by desensitizing patients with defined, precise amounts of key allergens. Aimmune has one FDA-approved medicine for peanut allergy and other investigational therapies in development to treat other food allergies.
About Nestle Health Science
Nestle Health Science (NHSc), a wholly owned subsidiary of Nestle, is a globally recognized leader in the field of nutritional science. At NHSc we are committed to empowering healthier lives through nutrition for consumers, patients and their healthcare partners. We offer an extensive consumer health portfolio of industry-leading medical nutrition, consumer and VMS brands that are science-based solutions covering all facets of health from prevention, to maintenance, all the way through to treatment. NHSc is redefining the way we approach the management of health in several key areas such as pediatric health, allergy, acute care, oncology, metabolic health, healthy aging, gastrointestinal health, and inborn errors of metabolism. Headquartered in Switzerland, NHSc employs over 5,000 people around the world who are committed to making a difference in people's lives, for a healthier today and tomorrow.
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