The therapy involves ingesting small doses of peanut protein, gradually increased over time to help desensitize patients to higher levels
U.S. health regulators approved the first drug for children and teenagers with peanut allergies, marking a potential paradigm shift in treatment.
The drug will be “a game changer for both food allergy doctors and patients,” according to Christina Ciaccio, an associate professor of pediatrics at the University of Chicago and an investigator for Palforzia in U.S. studies. “To date, we have not been able to do anything but tell patients to carefully monitor what they are eating and to always be prepared with an epinephrine autoinjector in case a reaction does occur.
The drug’s path to approval was rocky at times as a government shutdown to start 2019 meant the FDA didn’t begin reviewing Aimmune’s application as early as investors hoped. Shares have climbed since September when an advisory panel to the FDA voted in favor of the drug. Aimmune can “buck the trend” of the typical “short-the-launch” biotech thesis, Piper Jaffray analyst Christopher Raymond wrote in a note to clients in December.
Aimmune says it has identified about 1,300 allergists that they see as ready and willing adopters for the therapy when it becomes commercially available. Of that group, around 250 are already using do-it-yourself oral immunotherapy in their offices. Aimmune set the wholesale acquisition cost to $890 a month, regardless of the stage in patient dosing.
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