In recent developments, U.S.-based biopharmaceutical company Aimmune Therapeutics Inc. has reportedly received approval from the European Commission (EC) for using its oral immunotherapy, PALFORZIA to treat individuals with peanut allergy.
For the uninitiated, PALFORZIA is a biologic drug that is administered with a systematic dosage approach based on oral immunotherapy (OIT). The process involves the initial ingestion of the specific allergenic proteins in small quantities followed by a gradual increment in the amount to mitigate allergic reactions to the allergen. Furthermore, the drug is produced from a defatted powder of Arachis hypogaea L and is indicated in patients between the age of 4 to 17 years.
The recent development comes after two successful phases 3 clinical trials of the drug, namely Artemis and Palisade, cited sources with relevant information. The oral immunotherapy, in both the trials, met the primary objective and outperformed the placebo results.
President and CEO of Aimmune Therapeutics, Andrew Oxtoby was reported saying that the European Commission’s approval of the treatment is a significant milestone for the company. The company will now focus on launching the product in the United Kingdom and Germany in May 2021, he added.
Meanwhile, Greg Behar, CEO of Nestlé Health Science S.A., commented that the EC approval is the first treatment approved for peanut allergy in the European Union.
Reportedly, around 17 million people across Europe are affected by food allergies, among which peanut allergy is of the highest prevalence. Approximately 1.6% of European children develop the allergy at an early stage and are subject to life-threatening symptoms.
About Aimmune Therapeutics Inc.
Aimmune Therapeutics is a subsidiary of Nestlé Health Science S.A that functions as a clinical-stage biopharmaceutical firm. The California-headquartered organization focuses on commercializing and developing treatments for potentially life-threatening food allergies as well as other food-mediated ailments, primarily gastrointestinal conditions.
Source credits –