- The Food and Drug Administration on Friday approved the first treatment for peanut allergy, clearing Aimmune Therapeutics' immunotherapy Palforzia for use by the more than one million children and teens aged 4 to 17 in the U.S. who can't tolerate the food.
- Palforzia, which uses gradually increasing doses of peanut flour to desensitize patients over time, has stirred debate because of the number of anaphylactic reactions among participants in Aimmune's key study. An FDA advisory panel voted 7-2 in September to recommend the agency approve the drug.
- Approval gives Aimmune a head start of about six months on its nearest rival, DBV Technologies, which is using a patch-based delivery system to expose patients to increasing amounts of peanut antigen.
In clearing Palforzia, the FDA gave children and teens a way to guard against accidental exposure to peanuts, although people who take the drug must continue to avoid the food.
Aimmune describes Palforzia as an oral immunotherapy, referring to how the drug is designed to reduce the potentially life-threatening immune reactions those who are allergic to peanuts can experience.
Over several months, patients prescribed Palforzia are gradually given doses that begin at the equivalent of 1/600th of a peanut and eventually reach up to 300 mg of peanut protein.
At the end of the 24-week trial that Aimmune used to win approval, 67% of patients taking Palforzia were able to withstand exposure to 600 mg of peanut protein, compared with 4% of patients taking a placebo.
However, patients taking Palforzia in clinical study were more likely to discontinue treatment as well as more likely to have an allergic reaction and require use of epinephrine.
Due to that likelihood, Aimmune will be required to sell Palforzia through a Risk Evaluation and Mitigation Strategy program, which could limit uptake. The initial dosing as well as the first administration of each increased dose level must be done in a certified healthcare setting, and patients must have immediate access to epinephrine to protect against the risk of anaphylactic reactions.
Aimmune set the list price of Palforzia at $890 per month, or nearly $11,000 per year.
The annual cost, which falls in the middle of the $3,000 to $20,000 range Aimmune previously suggested, sets the biotech up for a commercial test in getting payers to cover Palforzia.
The Institute for Clinical and Economic Review, an influential cost watchdog, has said the drug would increase healthcare spending above its target budget threshold of $990 million a year if priced at an assumed cost of $4,200 a year.
The FDA's decision to approve Palforzia ends a long road for Aimmune, which had its initial application derailed by the 2019 shutdown of the federal government.
But the company may not have the market to itself for long. Rival DBV is slated for a decision on its competing product, called Viaskin Peanut, no later than Aug. 5, and is expected to be subject to review from an FDA advisory committee.