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EU authorises Aimmune’s peanut allergy treatment Palforzia

Approval in the EU comes nine months after US authorisation

Aimmune Therapeutics’ Palforzia has received approval from the European Commission (EC) for the treatment of a peanut allergy.

The EC has approved Palforzia for use in children aged four to 17 with a confirmed diagnosis of a peanut allergy.

The treatment must be accompanied by a diet that avoids peanuts. It is not intended for, and does not provide, immediate relief of allergic symptoms.

In Europe, 17 million people are affected by food allergies, with a peanut allergy being one of the most common. It is thought that around 1.6% of European children live with a peanut allergy, with estimations ranging from 0.24% to 2% depending on the diagnostic methods used.

The oral immunotherapy – previously known as AR101 – takes the form of defatted peanut flour that is sprinkled over food, given in tiny but gradually increasing amounts over a six-month period, to encourage the immune system to develop a tolerance to peanut antigens.

The EU approval, which comes nine months after authorisation in the US, is based on a range of data including results from two pivotal phase 3 trials, PALISADE and ARTEMIS.

In the ARTEMIS trial, the oral immunotherapy met the primary objective, outperforming placebo when it came to inducing a tolerance to a single 1,000mg dose of peanut protein – equivalent to three to four peanut kernels.

The earlier PALISADE study also found that 50.3% of Palforzia-treated patients tolerated a single highest dose of 1,000mg of peanut protein compared to 2.3% of placebo patients.

In September, Aimmune was acquired by Nestlé in a deal worth $2.6bn, helping the global company, which is mainly known for its food and wellness brands, expand into the health and life sciences sector.

In a statement, Aimmune president and chief executive officer (CEO) Andrew Oxtoby said that the company is preparing to launch Palforzia in Germany and the UK in May 2021.

“Today’s news of the EC approval represents the first-ever treatment option approved for a 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,” added Greg Behar, CEO of Nestlé Health Science.

Aimmune’s potential rival, DBV Technologies, has not had as much success with getting its peanut allergy treatment approved.

In August, DBV announced that it had received a complete response letter (CRL) from the US Food and Drug Administration (FDA) for its Viaskin peanut allergy treatment.

At that time, the company said that it was ‘in the process of engaging [the] FDA to discuss the regulatory path forward’.

Meanwhile, a marketing authorisation application for the product was recently validated by the European Medicines Agency (EMA), confirming that the submission is complete and marking the launch of the formal review process.

Article by
Lucy Parsons

21st December 2020

From: Regulatory



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