Aimmune’s Peanut Allergy Drug Wins Broad FDA Panel Backing
(Bloomberg) -- An advisory panel to the U.S. Food and Drug Administration voted in favor of Aimmune Therapeutics Inc.’s Palforzia to treat kids with peanut allergies.
Seven of the nine panelists voted that Palforzia is an effective therapy that warrants U.S. approval, while eight of them agreed that it’s safe enough for patients to use.
“It is not perfect and it is not necessarily for everybody,” but the safety and efficacy shown makes it worth considering, panelist Soheila Maleki said during the committee meeting’s discussion period. Maleki voted that Palforzia showcased both efficacy and safety that warranted approval.
The recommendation clears a hurdle for what would be the first approved therapy for an allergy that can cause life-threatening reactions and affects more than 1.6 million kids and teens. Palforzia, if approved, could reach blockbuster status by 2024, with peak sales nearing $1.9 billion, according to RBC Capital Markets.
Panelists supported a safety program to help ensure the benefits outweigh the risks and informed patients about the reactions that the desensitization therapy could trigger. The group also emphasized a desire for caregivers or patients to carry injectable epinephrine while on the medicine.
“This is exactly compatible with what our plans had been in terms of the requirement” for epinephrine, packaging for doses, and ensuring that each dose is administered at a facility where they are capable of managing any allergic reactions, Stephen Tilles, senior director of medical affairs at Aimmune, said by phone. “We look forward to the next steps with the FDA.”
An FDA decision is expected by late January, and while the agency typically heeds the advice of its panels, it isn’t obligated to follow it. Shares of Brisbane, California-based Aimmune were halted Friday during the advisory panel meeting, which happened to coincide with National Peanut Day.
The stock rose 15% on Wednesday after agency documents released ahead of the panel were viewed by Wall Street as “benign” and “supportive” of the medicine. Analysts said Aimmune shares could rise about 30% on a positive panel outcome. Options are pricing in a 21% move in shares by the end of next week.
For investors weighing Aimmune’s broader pipeline, which is built on similar medicines targeting allergies like eggs and tree nuts, the backing may also serve as a confirmation of the company’s technology.
“At any small biotech company your first asset, which is the validation of a platform, is pretty damn important to get through,” Aimmune Chief Executive Officer Jayson Dallas said in an interview this month. “Validation of the platform and its concept will speed up our egg program and create more excitement for the egg program and our tree nut program.”
The FDA panel’s decision may also shed some light onto what’s next for DBV Technologies SA and its experimental patch for peanut allergies. The company submitted an application with U.S. regulators last month for use in children ages four to 11.
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