EU Approval: FIRST treatment for Peanut Allergy

In January 2021 the European Commission approved first treatment for peanut allergy.
Earliest launch in Germany and the UK in May 2021.

Aimmune Therapeutics’ PALFORZIA®

The European Commission (EC) has approved PALFORZIA® [defatted powder of Arachis hypogaea L., semen (peanuts)] for the treatment of peanut allergy, making it the first treatment for the condition. Produced by Aimmune Therapeutics, PALFORZIA is indicated in patients aged four 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.

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 pharmaceutical-grade OIT for peanut allergy with a well-defined allergen profile to assure the consistency of every dose, from 0.5mg (equivalent to 1/600th of a peanut) to 300mg.

The approval was based on a package of data including two pivotal Phase III clinical trials, PALISADE and ARTEMIS. The trial tested the treatment in 671 participants with peanut allergy in North America and Europe. In both studies, PALFORZIA treatment resulted in a significant increase in the amount of peanut protein tolerated, compared to placebo. Participants underwent an initial dose escalation period for 20 to 40 weeks starting at 3mg until the 300mg dose was reached. Participants then underwent six months (PALISADE) or three months (ARTEMIS) of maintenance immunotherapy with 300mg PALFORZIA or placebo until the end of the study.

“Results from landmark Phase III 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 Professor George du Toit, study investigator for the PALISADE and ARTEMIS trials.

Prevalence

The prevalence of peanut allergies, the most common food allergy in children, has tripled in the past 2 decades. Today, up to 2.5% of the paediatric population has been diagnosed with a peanut allergy. However, the true prevalence of food allergies is unknown. Those with a family history of allergy, asthma, or eczema, may be at increased risk.

How does Peanut Allergy occur?

A peanut allergy occurs when a person’s immune system fails to recognize peanut protein and overreacts to it.

Genetic factors but also environmental factors can explain the allergy.

Family history, rash occurrences, and exposure to soy protein were linked to childhood peanut allergy development in one study, but there is no clear answer as to why one child gets one peanut allergy and another doesn’t.

What are the symptoms of Peanut Allergy?

Peanut allergies usually appear in childhood, but in principle they can appear at any age. More serious reactions usually start at an earlier age.

The effects usually start immediately after exposure to peanuts or products containing peanuts. Symptoms usually start within a few minutes of exposure but can last up to two hours.

Peanut allergy symptoms:

  • Skin reactions such as rash, hives or eczema
  • Gastrointestinal (GI) symptoms like nausea, stomach pain, vomiting, or diarrhea
  • Watery eyes, coughing, or a runny nose

Severe Reactions

Peanut allergies can cause life-threatening reactions. These reactions may be preceded by skin, GI or upper respiratory symptoms, or they can begin suddenly.

Signs of a life-threatening peanut induced reaction:

  • Upper respiratory symptoms including coughing, or a runny nose
  • Wheezing
  • Swelling, also known as angioedema, of the lips, tongue, face, or throat
  • Severe reactions, called Anaphylaxis, may occur, causing lightheadedness, trouble breathing, or loss of consciousness

Peanut allergies are more likely than other food allergies to cause Anaphylaxis. Anaphylaxis is a medical emergency that requires prompt treatment.

Most of the deaths related to food allergy are associated with peanut ingestion and Anaphylaxis.

 

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