First peanut allergy drug wins approval United States
The first drug to prevent potentially life-threatening allergic reactions to peanuts has been approved by the US Food and Drug Administration (FDA), providing children and families with a long-awaited treatment option.
The therapy, Palforzia, isn’t a cure, and comes with significant risks of triggering the very reactions it is supposed to quell.
But for families and children who have reengineered their routines to minimise potential exposure to peanuts – changing how and whether they travel, eat out, socialise and feel safe in their daily lives – it could offer an important layer of protection and relief.
Palforzia is seen as an important test case for a new generation of therapies expected to transform how a rising epidemic of food allergies are treated.
Doctors who have had few tools other than counselling their patients to assiduously avoid peanuts expect that other drugs will follow. Aimmune Therapeutics, which makes Palforzia, has several other food allergy treatments in its pipeline.
Allergists say the drug will not be appropriate for every family. It is approved for children aged four to 17, and requires them to eat increasing doses of peanut protein to gradually desensitise their allergies.
This means patients must intentionally expose themselves to the very substance that triggers a life-threatening reaction under the regimen, called oral immunotherapy.
Due to the risks, patients must take some doses under a doctor’s supervision. The drug can cause severe allergic reactions and require epinephrine injections. It is unclear how long patients will have to stay on it.
Palforzia, which will carry a list price of US$890 (NZ$1380) per month, could also reignite discussions about high drug prices, although the company will offer an assistance programme to drop a patient’s share of the cost to as low as US$20 (NZ$30).
Some doctors have already used oral immunotherapy to desensitise people to peanut allergies, using commercially available, inexpensive peanut flour. Proponents of Palforzia argue that having a drug available could standardise the treatment.
A study by the Institute for Clinical and Economic Review, which evaluates whether drugs are worth the price, found that there wasn’t sufficient evidence that Palforzia was better than strictly avoiding peanuts or than current immunotherapy using peanut flour.