First Oral Immunotherapy Drug ‘Palforzia’ gets FDA Approval

The Anaphylaxis Campaign is delighted to hear about the success of Aimmune Therapeutics, Inc. in the approval of their oral immunotherapy drug, Palforzia, by the US Food and Drug Administration (FDA). This is the first oral immunotherapy drug that has been approved by the FDA. It currently does not have license for use in the UK.

Palforzia is an oral drug that delivers peanut protein. Through a desensitisation approach, the patient is given increasing doses of peanut protein occurring over several months under the supervision of a healthcare professional. A maintenance phase proceeds this, which requires patients to continually take a daily dose of the drug. This is available for use in patients aged 4 to 17 years. Palforzia was not found to be significantly effective in participants aged 18 to 55 years when compared with the placebo group.

Studies have been conducted in participants in the US, Canada and Europe to assess its effectiveness. The results showed that 67% of Palforzia recipients tolerated a 600mg dose of peanut protein in the challenge, compared to 4% of the placebo recipients.

Whilst Palforzia is not a cure for peanut allergy, it provides protection against reactions to accidental peanut exposures.

Palforzia will only be available through specially certified healthcare providers, health care settings and pharmacies to patient who are enrolled in the Risk Evaluation and Mitigation Strategy (REM) program in the US.

Please find out more information about Palforzia here

Aimmune Therapeutics, Inc. is also looking into immunotherapy for egg allergy and tree nut allergy. Please read our factsheet for more information about immunotherapy here