The Food and Drug Administration is bringing together a panel of outside experts to review a novel but controversial treatment that aims to protect people against severe peanut allergy.
The convening of the FDA advisory panel, scheduled to meet — and vote — on Sept. 13, will be a pivotal moment for Aimmune Therapeutics, the biopharma company that developed the new treatment, called AR101. If approved, AR101 will be the first protective therapy for peanut allergy and the start of what Aimmune hopes will be a family of products with blockbuster commercial potential — all designed to benefit the millions of people who suffer with life-threatening food allergies.
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As a parent with two children with food allergies who is also an advocate, this is a very balanced and well-covered piece. The genie has been let out of the bottle a long time ago with private practice OIT, so I too am anxious to learn how this panel will hear the patients stories and not dismiss them as overzealous parents instead of people whose stress diminishes the quality of life.
I worked for an ad agency on EpiPen for about 5 years as the lead marketing/brand/creative strategist, so I have some familiarity with all of this. It is literally impossible to 100% avoid peanut exposure, at least in the developed world. You are living life at risk of life threatening anaphylaxis every day. That is the correct context to evaluate this treatment. If I was preparing for an advisory panel, I would make sure parents and patients living with this were recruited and coached up to tell their stories.
I understand that it is pure speculation, but what is your opinion on the outcome of the 9-13 Adcom and ultimate FDA decision, thank you.