Aimmune’s Palforzia is first peanut allergy drug cleared in US

The first drug to treat peanut allergy, Aimmune’s Palforzia, has been approved by the US Food and Drug Administration for use in children, causing shares in the Nasdaq-listed biotech to spike.

The oral immunotherapy – previously known as AR101 – takes the form of defatted peanut flour that is sprinkled over food, given in tiny but gradually increasing amounts over a six-month period, to encourage the immune system to develop tolerance to peanut antigens.

The FDA has cleared Palforzia for use in children aged four to 17 with a confirmed diagnosis of peanut allergy, but notes that it isn’t a cure and they must continue to avoid exposure to peanuts in their daily diets, and also keep taking a daily dose of the immunotherapy as a maintenance therapy.

There are around 1.8 million people with peanut allergy in the US, 1 million of them children, and it is the leading cause of death from food-induced allergic reactions in the US. The FDA estimates that only one in five children diagnosed with the allergy eventually outgrow the condition.

“Even with strict avoidance, inadvertent exposures can and do occur,” commented Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER).

Antihistamines and epinephrine can be used to treat allergic reactions, but severe reactions can be fatal even with appropriate, prompt treatment, says the regulator.

“When used in conjunction with peanut avoidance, Palforzia provides an FDA-approved treatment option to help reduce the risk of these allergic reactions in children with peanut allergy,” added Marks.

There has been some debate about the safety of the treatment, given that there were a few cases of anaphylactic reactions among patients in the clinical trials of the immunotherapy which required rescue with epinephrine injections, but the FDA has decided in this instance the benefits outweigh the risks.

The company has agreed to make Palforzia available through a Risk Evaluation and Mitigation Strategy programme, designed to make sure it is used as directed and with medical supervision.

California biotech Aimmune has been in a race to market with rival companies like France’s DBV Technologies, which filed for approval of its Viaskin Peanut skin patch-based product at the end of 2018 in the US, but was forced to withdraw the application because of FDA concerns about manufacturing data. It refiled the application last August.

The approval gives Aimmune a few months’ lead at least in the US market, and the prospect of Palforzia’s approval has been weighing on DBV’s share price in the last few weeks. Aimmune has also filed for approval in Europe, with a verdict due later this year.

The Institute for Clinical and Economic Review (ICER) has already indicated that it thinks Palforzia is cost-effective at the proposed price of between $5,000 to $10,000 for the first six months of use, and $300 to $400 per month thereafter.

Analysts at GlobalData have suggested the market for peanut allergy products in eight major world markets could be worth $4.5bn in 2027, with Aimmune claiming a two-thirds share.