Aimmune: FDA Panel Nod Pushes Peanut Allergy Treatment One Step Closer To Potential Approval

Sep. 25, 2019 4:11 PM ETAimmune Therapeutics, Inc. (AIMT)30 Comments


  • An FDA advisory panel recommended 7-2 that Palforzia should be approved for the treatment of peanut allergy.
  • The benefits of patients receiving Palforzia greatly outweigh the risks, especially since there have been so many accidental deaths that could have been prevented.
  • Palforzia gives minimal peanut exposure over time so that a patient can overcome an allergic reaction which is dangerous. However, the need to carry epinephrine on hand should counteract this issue.
  • Aimmune Therapeutics had $250.3 million in cash as of June 30, 2019, with enough cash to fund operations for at least the next 12 months and to get through two regulatory approvals which are the U.S. and Europe.
  • I do much more than just articles at Biotech Analysis Central: Members get access to model portfolios, regular updates, a chat room, and more. Get started today »

Aimmune Therapeutics (NASDAQ:AIMT) recently had an advisory panel convene to determine if its peanut allergy treatment Palforzia (AR101) should be recommended for approval. The final vote in terms of recommending possible approval of the drug was highly positive. The panel did back the safety of the drug; however, the label will have to include a black box warning. The thing is that this type of treatment, should it be approved by the FDA, will be a good way for patients to get over their peanut allergy. It is a large market opportunity in the billions, but the number one question is, will such a market be attainable? I believe so and this is based on the ability to reduce accidental deaths from peanut allergy.

FDA Panel Backs Peanut Allergy Treatment

The FDA advisory committee backed the peanut allergy treatment Palforzia from Aimmune with a positive vote of 7-2. Such a vote is not a total predictor in that the FDA will decide to approve the drug, but the advisory committee giving such a vote increases the odds. Then on top of that, the safety also got a good vote from panel of 8-1. This means Palforzia has a good shot at receiving FDA approval for reducing peanut allergy in patients ages 4-17 who have a confirmed diagnosis of peanut allergy.

The thing is that it all appears good, but there might be a problem that might pose a risk. This involves a REMS in place, which would be needed to reduce or prevent any issues arising from an allergic reaction when given treatment. It is likely that any patient given Palforzia must have a prescription for injectable epinephrine on hand. Why is this important? That's because treatment with Palforzia is incremental exposure to peanut protein. In that instance, an allergic reaction could occur when a patient is either given the first dose of treatment or slowly increasing dose levels. As you can imagine, this is a necessary REMS strategy in place.

The label will also include a black box warning. However, the black box label is not surprising given the nature of this type of treatment. Especially, since these patients who are allergic to peanuts are exposed to it gradually. There will be proponents who will try to shut down such a treatment. While it is risky, I believe the REMS strategy in place will handle any major issues from arising.

On top of that, I like to look at the game changing positive aspect of this treatment. This would possibly allow patients to reduce the potential for any severe allergic reaction for peanut exposure. Why is this important? Consider that while severe allergic reaction deaths are rare, they can happen accidentally. Even if minimal exposure to peanut protein can save one life, that would be a very important outcome. Such an aspect is the likely reason why the panel voted the way they did. They figured that treatment of Palforzia outweighed the risks.


According to the 10-Q SEC Filing, Aimmune Therapeutics has $250.3 million in cash, cash equivalents and investments as of June 30, 2019. The biotech is in good shape when it comes to its balance sheet. That's because it has stated it has enough cash on hand to fund the commercialization of both the U.S. and European approval. Not only that, but it will still even have cash left over to fund the other products being developed in the pipeline. That means the cash on hand is enough that the company can fund itself for at least the next 12 months without needing to raise additional capital.


The FDA panel seems to be on board with recommending treatment with Palforzia for peanut allergy. The risk is that even though the panel recommended the treatment for approval, doesn't mean it's guaranteed to be approved. That's because while the FDA takes its advisory panel's recommendation into account, it is not inclined to follow it. It could break away from its advisory panel and not approve the drug. However, I think there is a good chance for approval. Especially, when you consider that the treatment will likely carry a black box warning label talking about the risks of taking such a treatment. On the flip side, I provided evidence above about accidental deaths that can be avoided if a treatment like Palforzia is approved. I can understand the concerns of an allergic reaction while taking such a treatment, but with patients having epinephrine on hand at a moment's notice, this should squelch any of these concerns. If Palforzia is approved, it would be the first type of treatment specifically given the green light for marketing for peanut allergy.

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