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Peanut allergy pill gets thumbs-up from FDA advisory panel



During initial dose escalation and up-dosing combined, 6.1% of patients in the active group and 3.1% in the placebo group had a systemic reaction requiring epinephrine. This was most often administered outside of the clinic.

There were 12 cases of eosinophilic esophagitis, all of which resolved after withdrawal from the study medication.

Aimmune submitted a risk-management proposal that includes the following:

  • The first dose of each progressive dose must be administered in a facility that is equipped to treat systemic allergic reactions.
  • Families must have a valid prescription for injectable epinephrine before treatment starts and must demonstrate that they know how to use it.
  • There must be distribution controls in every pharmacy that dispenses the product.
  • Packaging will be dose specific to ensure proper at-home administration.
  • Pharmacologic questionnaires will be used as data collection instruments.
  • Professional and patient-focused labeling will include a medication guide and educational material.

Palforzia is not the only peanut desensitization product in the works. DBC Technology has resubmitted its biologics license application to the FDA in the hope of getting approval for its peanut allergy treatment, the Viaskin Peanut patch.

The patch is designed to desensitize allergic children aged 4-11 years through a skin-patch method known as epicutaneous immunotherapy. Results from two controlled clinical trials were included in the submission. The company is also investigating the potential of this form of skin-patch therapy for milk and egg allergies.

Correction, 9/15/19: An earlier version of this article did not clearly state that the panel recommended approval rather than granted approval for the drug.


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