Aimmune’s peanut allergy med Palforzia wins EU approval

The European Commission (EC) has approved Aimmune Therapeutics’ Palforzia, making it the first treatment for peanut allergy in the EU, according to the firm.

Following the EC approval, Palforzia will be available to patients aged four to 17 years with a confirmed diagnosis of peanut allergy.

It is not, however, indicated for the treatment of allergic reactions – including anaphylaxis – and must be used in conjunction with a peanut-avoidant diet.

The drug can also be continued in patients aged 18 years or older, Aimmune added in a statement.

The EC approval was based on a data package including two phase III clinical trials – PALISADE and ARTEMIS.

Across both studies, Palforzia treatment led to a significant increase in the amount of peanut protein tolerated in participants with peanut allergy, compared to placebo.

“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 chief executive officer of Aimmune Therapeutics.

“We are grateful for the efforts of the peanut allergy community who contributed to the development programme. 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,” he added.

In February, Palforzia was approved by the US Food and Drug Administration (FDA) for the treatment of patients with peanut allergy.

Peanut allergy is one of the most common food allergies in the world, affecting more than 1.6 million children and teens in the United States alone.