Aimmune wins approval for peanut immunotherapy, charges 10k+
The FDA has approved the first treatment for peanut allergy, although it comes with some controversy.
Unlike most of the controversial drugs that come before the FDA, the bulk of questions don’t center around this drug’s effectiveness or side effects.
Palforzia, developed by Aimmune, has been shown to prevent the most severe reactions from exposure to small amounts of peanuts. In a Phase III trial, children given escalating doses of the drug were then given 600 mg peanut protein — about 2 peanuts — had a 67% chance of avoiding a severe reaction. For the placebo patients, the figure was 4%.
“The goal — step 1 in terms of therapy — is to be able to treat a child to the point you can say, if that child goes into the community and accidentally gets exposed to a peanut somewhere, they’re not going to have a life-threatening event,” Aimmune CEO Jayson Dallas told Endpoints News in an interview at the JP Morgan conference earlier this month.
“They may have a no reaction at all, they may have a little tingling, but they’re not going to be at risk.”
The FDA advisory committee pointed out that this wasn’t ideal — you can’t eat a peanut butter sandwich and a significant number of the patients couldn’t even eat the 2 peanuts — and noted the adverse reactions some had to the pill. But largely, they agreed it was a substantial step forward for a condition that has seen virtually no innovation.
Critics, though, have pointed to what’s in the drug: peanuts. Palforzia is a form of immunotherapy, by which prolonged exposure to an allergen — in this case, peanut powder, mostly but not entirely equivalent to what you can find on a supermarket shelf — is used to build up resistance. Some doctors have long done this without any prescribed drug and to some success. In a 2018 study, researchers started 270 patients on 1/2,500th of a peanut and worked 80% of them up to 12 peanuts.
Palforzia, opponents say, would take this off-label treatment and charge thousands of dollars for it. Analysts had projected a little over $4,000 for the price and over $1 billion in peak sales. The actual annual price, Aimmune announced today, will be $10,680.
The Institute for Clinical and Economic Review also pointed to some of the adverse effects patients experienced from receiving the drug, and said the long-term benefit wasn’t clear enough to justify the cost and those adverse effects.
Aimmune has said those risks are to be expected when exposing patients to an allergen. They argued that while doctors can prescribe patients off-label peanut powder, they are exposed to lawsuits for any reaction a kid could have to the powder. By bringing the drug into the medical system, they say they give an option for doctors to prescribe patients without making themselves liable.
The drug is approved for children ages 4 to 17. Aimmune said they plan to hold presentations and workshops to train 1,300 allergists on how to administer the drug.