The European Commission has approved the Aimmune Therapeutics drug PALFORZIA®, making it Europe’s first approved peanut allergy therapy. This comes nine months after PALFORZIA was approved by the US FDA for use in children aged four to 17 with a confirmed diagnosis of a peanut allergy.
PALFORZIA is an oral immunotherapy (OIT) product that allows doctors to prescribe specific doses of defatted peanut proteins to be ingested daily in small amounts that are incrementally increased over time. Continuous treatment over several months and years can result in mitigation of peanut allergy symptoms. The treatment must be accompanied by a diet that avoids peanuts as it is not intended for, and does not provide, immediate relief of allergic symptoms.
The USA and EU approvals are based on a range of data including results from two phase 3 trials, PALISADE and ARTEMIS. In the ARTEMIS trial, the oral immunotherapy was shown to outperform placebo doses in inducing tolerance to a single 1,000mg dose of peanut protein – equivalent to three to four peanut kernels. Earlier, the PALISADE study was able to demonstrate that half the patients treated with PALFORZIA could tolerate a single high dose of 1,000mg of peanut protein compared to 2.3% of placebo patients.
Aimmune Therapeutics, a Nestlé Health Science Company, is said to be preparing to launch PALFORZIA in Germany and the UK in May 2021.
See the Aimmune Therapeutics media release for further details.
The Australasian Society of Clinical Immunology and Allergy (ASCIA) prepared an OIT fact sheet in 2020 to provide the latest summary of OIT as it relates to Australia and New Zealand. As yet, no OIT products for food allergies are registered by the Therapeutic Goods Administration (TGA) in Australia or Medsafe in New Zealand.