European Commission Approves Aimmune’s PALFORZIA® as First-Ever Treatment for Peanut Allergy in the EU

Aimmune Therapeutics, Inc., a Nestlé Health Science Company, today announced that the European Commission (EC) has approved PALFORZIA^® [defatted powder of Arachis hypogaea L., semen (peanuts)] for the treatment of peanut allergy. PALFORZIA is indicated in patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy in conjunction with a peanut-avoidant diet and may be continued in patients 18 years of age and older.

"Today’s approval is a historic moment for the millions of people living with potentially life-threatening peanut allergy, and we are proud to bring PALFORZIA to patients in the EU who, until now, have not had an approved therapeutic option,” said Andrew Oxtoby, President and CEO of Aimmune Therapeutics. "We are grateful for the efforts of the peanut allergy community who contributed to the development program. Now we turn our efforts toward working with health authorities to ensure access of 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.”

"Today’s 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, including prescription medicines for food allergy,” said Greg Behar, CEO of Nestlé Health Science.

Food allergies affect around 17 million people across Europe.¹ Peanut allergy is one of the most common food allergies in Europe, with the prevalence doubling among children between 2005 and 2015.^1,2,3 The incidence of hospital admissions due to severe allergic reactions also increased seven-fold, and around two-thirds of schools in Europe have at least one child at risk of anaphylaxis.¹ Analyses in multiple European countries estimate that around 1.6% of European children live with peanut allergy, with estimations ranging from 0.24% to 2% depending on the diagnostic methods used.⁴ Severe reactions, which can be life threatening, and the difficulty of avoidance create an urgent need for treatment.⁵

"Results from landmark Phase 3 clinical trials have shown more than half of patients treated with PALFORZIA were able to tolerate the equivalent of seven to eight peanut kernels after up to nine months of treatment. These compelling data highlight its potential to mitigate against severe allergic reactions, including anaphylaxis in the event of unintended exposure to peanut protein,” said Prof. George du Toit, M.B., B.Ch., Professor of Paediatric Allergy at Evelina London Children’s Hospital, Guy's and St Thomas' NHS Foundation Trust, King’s College London and study investigator for the PALISADE and ARTEMIS trials. "Today’s announcement is a very important step and means that we are closer than ever before to being able to provide an approved treatment for patients with peanut allergy.”

The approval was based on a package of data including two pivotal Phase 3 clinical trials, PALISADE and ARTEMIS.^6,7,8 In both studies, PALFORZIA treatment resulted in a significant increase in the amount of peanut protein tolerated, compared to placebo.⁷

"The incidence of peanut allergy has been increasing across Europe and the threat of accidental exposure is an everyday reality for people with peanut allergy as avoidance is difficult. As a result, many patients and their families suffer a daily toll of uncertainty, stress and fear of a severe reaction,” said Sabine Schnadt, food allergy and anaphylaxis expert at Deutscher Allergie und Asthmabund e.V. (DAAB), a German allergy advocacy organization. "A treatment option which provides an additional level of protection has long been awaited in the peanut allergy community and so we are thrilled with today’s news.”

About PALFORZIA

PALFORZIA is a complex biologic drug used with a structured dosing approach that builds on a century of oral immunotherapy (OIT) research. With OIT, the specific allergenic proteins are ingested initially in very small quantities, followed by incrementally increasing amounts, that can result in the ability to mitigate allergic reactions to the allergen over time. PALFORZIA is a rigorously developed, pharmaceutical-grade OIT for peanut allergy with a well-defined allergen profile to assure the consistency of every dose, from 0.5 mg (equivalent to 1/600th of a peanut) to 300 mg.

PALFORZIA is not intended for, and does not provide, immediate relief of allergic symptoms. Therefore, this medicinal product is not to be used for emergency treatment of allergic reactions, including anaphylaxis. Self-injectable adrenaline (epinephrine) must be available to the patient at all times.

About the PALISADE and ARTEMIS Phase 3 Clinical Trials

PALISADE (Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization) and ARTEMIS (AR101 Trial in Europe Measuring Oral Immunotherapy Success) evaluated the efficacy and safety of PALFORZIA in 671 participants aged 4 to 17 with peanut allergy in North America and Europe.

Participants enrolled represented a highly allergic population with a high prevalence of comorbidities who reacted to low doses of peanut protein at the screening double-blind, placebo-controlled food challenge (DBPCFC). Participants underwent an initial dose escalation period for 20 to 40 weeks starting at 3 mg until the 300 mg dose was reached. Participants then underwent six months (PALISADE) or three months (ARTEMIS) of maintenance immunotherapy with 300 mg PALFORZIA or placebo until the end of the study.

The primary efficacy endpoint in both studies was the proportion of participants who tolerated a single highest dose of at least 1,000 mg peanut protein (equivalent to seven peanut kernels cumulatively) with no more than mild allergic symptoms at the exit challenge. Key secondary endpoints included desensitization response rates after single doses of 300 mg and 600 mg peanut protein and the maximum severity of symptoms at the exit challenge.⁷

The safety profile was as expected for an oral desensitization therapy. The most common adverse reactions (of any severity) were abdominal pain (49.4%), throat irritation (40.7%), pruritus (33.7%), nausea (33.2%), vomiting (28.5%), urticaria (28.5%), oral pruritus (26.0%), abdominal discomfort (22.9%), and abdominal pain upper (22.8%).⁷

About Aimmune

Aimmune Therapeutics, Inc., a Nestlé Health Science Company, is a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies and other food-mediated conditions, including gastrointestinal conditions. Aimmune Therapeutics has one FDA- and EU-approved medicine for peanut allergy and other investigational therapies in development. For more information, please visit www.aimmune.co.uk.

About Nestlé Health Science

Nestlé Health Science (NHSc), a wholly owned subsidiary of Nestlé, 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 vitamins, minerals and supplements (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. www.nestlehealthscience.com.

¹ EAACI. Food Allergy & Anaphylaxis Public Declaration, 2015. Available at: http://dgaki.de/wp-content/uploads/2014/04/FoodAllergyAnaphylaxisPublicDeclarationCombined.pdf. Accessed: 13 Nov 2020

² Du Toit G, et al. Randomized Trial of Peanut Consumption in Infants at Risk for Peanut Allergy. N Engl J Med 2015; 372: 803-13

³ Worldallergy.org. 2019. Food Allergy World Allergy Organization. Available at: https://www.worldallergy.org/education-and-programs/education/allergic-disease-resource-center/professionals/food-allergy

⁴ Nwaru BI, et al. The epidemiology of food allergy in Europe: a systematic review and meta-analysis. Allergy 2014; 69: 62–75.

⁵ Bock SA, Muñoz-Furlong A, Sampson HA. Fatalities due to anaphylactic reactions to foods. J Allergy Clin Immunol. 2001;107:191-3.

⁶ PALFORZIA. Summary of Product Characteristics.

⁷ Vickery BP, et al. AR101 oral immunotherapy for peanut allergy. New Engl J Med 2018; DOI: 10.1056/NEJMoa1812856

⁸ Hourihane JO, et al. Efficacy and safety of oral immunotherapy with AR101 in European children with a peanut allergy (ARTEMIS): a multicentre, double-blind, randomised, placebo-controlled phase 3 trial. Lancet Child & Adolescent Health. 2020; 4:10: 728-739.

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