Aimmune is seeking approval of its peanut allergy immunotherapy product, Palforzia. We have extensively discussed AR101 a Potential Peanut Allergy Cure nearly a year ago, and the FDA is set to make a decision on it very soon.
Traditionally peanut allergies are managed by avoidance but the threat of accidental exposure cannot be nullified. In the US, peanut allergy affects nearly 1.2% of the total population.
Palforzia is a small amount of peanut flour that is given in escalating doses to desensitize a persons allergy and then a maintenance dose is continually administered. Palforzia has undergone two late stage trials. The results have been very positive, with about 67% of patients able to to consume 600mg of peanut protein. How much peanut will cause an allergic reaction?
Nearly 80% of those patients were able to tolerate at least 1000mg of peanut protein, and half of those a 2000mg dose. Aimmune chief believes they will no longer need therapy 3-5 years down the road.
But safety can be an issue. 11% of patients withdrew due to side effects, additionally over the course of treatment 14% of patients receiving Palforzia received epinephrine. The FDA staff underscored these findings by writing “Palforzia treatment group had an increased number of discontinuations, systemic allergic reactions and eosinophilic esophagitis compared to the placebo treated group.” There has been some concern in other studies too of higher rates of anaphylaxis of patients who have undergone desensitization.
Aimmune and arch rival DBV Technologies have been locked in a race to market their peanut allergy treatments. Development Program: Viaskin® Peanut
The treatment cost of Palforzia is expected to cost about $4,200/year and Viaskin Peanut at $6,500/year. An FDA decision for AR101 is expected in January 2020.
Update 9/13/2019 Palforzia was voted to be approved by an advisory committee to the FDA (which they usually follow). They voted 7-2 that it works well, and 8-1 that it is safe. It will carry a black box warning, and will require patients to have an injectable epinephrine and that the initial dose and updosing to be done at a medical office capable of treating anaphlaxis.