Nestlé has announced that the European Commission has approved the use of Aimmune's peanut allergy treatment Palforzia in the EU.
The approval is based on a package of data, including from two phase-three clinical trials, Palisade and Artemis, the food giant added.
In both studies, Palforzia treatment resulted in a significant increase in the amount of peanut protein tolerated, compared to placebo.
'End-To-End Solutions'
Greg Behar, the CEO of Nestlé Health Science, said, "The news of the EC approval represents the first-ever treatment option approved for peanut allergy in the EU and underscores our vision of providing end-to-end solutions as a driver of wellness and treatment, in the key growth areas of nutrition, metabolism, healthy aging and food allergy."
The treatment has been developed by Aimmune Therapeutics, Inc., which was recently acquired by Nestlé Health Science.
Palforzia is an oral immunotherapy for patients aged four to 17 years with a confirmed peanut allergy diagnosis.
It may be continued in patients who are 18 years and older and must be used in conjunction with a diet devoid of peanuts.
A marketing authorisation application for Palforzia has been filed in Switzerland with Swissmedic and is currently under review.
Food Allergy
Food allergies affect around 17 million people across Europe, with peanut allergy being one of the most common.
Between 2005 and 2015, peanut allergy doubled among children and the number of hospital admissions due to severe allergic reactions increased seven-fold, Nestlé added, citing data from the European Academy of Allergy and Clinical Immunology (EAACI) and World Allergy Organisation.
President and CEO of Aimmune Therapeutics, Andrew Oxtoby, said, "Now we turn our efforts toward working with health authorities to ensure access to this first-of-kind treatment for those children with peanut allergy for whom our product is appropriate as we prepare to launch in Germany and the UK in May 2021."
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