FDA’s Advisory Committee Recommends Palforzia’s approval for Peanut Allergy Treatment

By Rajaneesh K. Gopinath, Ph.D.

The committee voted 7-2 in favor of Aimmune Therapeutics’ oral immunotherapy drug, Palforzia to be approved for patients suffering from peanut allergy. If the recommendation is followed, the drug would become the first FDA approved treatment for this condition.

On September 13^th, the Allergenic Products Advisory Committee (APAC) convened by the US Food and Drug Administration met to deliberate whether the efficacy and safety data provided in the Biologics License Application (BLA) of Palforzia (AR101) supports its licensing. The advisory panel gave a non-unanimous decision by voting 7-2 in favor of its approval. The drug is recommended for the treatment of children belonging to the age group 4 through 17, who have a confirmed diagnosis of peanut allergy.

APAC Recommends FDA’s Safety Plan

Additionally, the panel also voted 8-1 in favor of a Risk Evaluation and Mitigation Strategy (REMS) to accompany with the drug approval. REMS is a drug safety program required by the FDA to ensure that benefits outweigh risks when a drug is administered. Accordingly, patients who are prescribed Palforzia as a treatment must have a valid prescription for injectable epinephrine and caregivers/patients must attest to carrying it while on treatment. Additionally, initial dose escalation and the first dose of each up-dosing level must be administered in a certified facility capable of treating systemic allergic reactions.

Clinical Trials Supporting the Approval

The BLA includes efficacy and safety data from 7 clinical studies that comprise of 2 phase II and 5 phase III studies. ARC003 is a phase III, randomized, double-blind, placebo-controlled, multicenter study that evaluated the efficacy and safety of Palforzia in 555 patients, in which 499 of them were between 4 and 17 years. The primary efficacy endpoint of the study is the proportion of subjects who tolerated a dose of at least 600 mg of peanut protein without severe adverse reactions. The success criterion was met for the subject population with a significant treatment difference (efficacy) estimate of 63.2% (95% CI: 53.0, 73.3).

Controversy Surrounding Palforzia

Palforzia is an oral immunotherapy drug candidate which comprises of 600 mg of peanut powder given in increasing doses. One of the reasons for the non-unanimous verdict of the panel is the argument that Palforzia wouldn’t provide an ultimate cure. Rather it just increases the threshold of patients to peanut allergen very minimally. The major goal of the therapy is to protect patients from life-threatening allergic reactions if they were to ingest peanut products accidentally. It would not give them the ability to consume peanuts regularly in their diet. Therefore, a section of people feel that the treatment is nothing but buying peanuts for a large sum of money. However, a peanut allergy community consisting of many kids, parents and physicians are rendering their support for the approval of Palforzia. David M. Lang, MD, president of the American Academy of Allergy, Asthma & Immunology (AAAAI) also supported the decision. “After today’s meeting, we are another step closer to having the first FDA approved therapy for peanut allergy; this is truly a groundbreaking development. Patients and their families have been waiting for this for many years and will be eagerly awaiting the FDA’s final decision.” he said.

Aimmune Therapeutics’ stocks went up by almost 17% following the committee meeting. It remains to be seen whether the FDA will act on this recommendation and approve the drug.

References

1. http://ir.aimmune.com/news-releases/news-release-details/fda-allergenic-products-advisory-committee-votes-support-use
2. https://www.aaaai.org/about-aaaai/newsroom/news-releases/food-session?utm_source=facebook
3. https://www.fda.gov/media/130653/download

Author

Rajaneesh K. Gopinath