FDA schedules Aimmune's peanut allergy drug for September expert review | BioPharma Dive

Dive Brief:

• Aimmune Therapeutics said Thursday the Food and Drug Administration's advisory committee on allergenic products will review its experimental peanut allergy pill in September, setting a date for an initial test of the growing allergy desensitization field.
• The Sept. 13 meeting is two months ahead of expectations, RBC Capital Markets analyst Kennen MacKay wrote in a May 16 research note. The quicker timeline raises the possibility for an FDA decision, and a potential commercial launch, before year's end, he wrote. Aimmune expects a decision may come as late as January 2020.
• The San Francisco-area biotech had its Biologics License Application for AR101 accepted in March, following an unusual dispute over how the FDA should classify the drug review. The agency ultimately agreed to review the application, but not after the recent government shutdown resulted in delays.

Dive Insight:

Even as its regulatory review progresses, Aimmune still argues the FDA incorrectly interpreted the statute governing review of allergenic products.

The agency's interpretation led it to exempt Aimmune's drug AR101 from a review under the Prescription Drug User Fee Act process. Instead of the standard 10-month review for drugs under PDUFA, Aimmune expects a regulatory decision within a year.

"We still have a fundamental disagreement with the FDA," CEO Jayson Dallas said in an interview with BioPharma Dive earlier this week, adding the agency gave them "no rational reason" for their decision.

"It was really frustrating for us," he added. "We worked really hard to get our BLA submitted in December ... before the shutdown. The shutdown should not have affected us."

But the 35-day government closure did, stalling the FDA's acceptance of Aimmune's application. With government agencies largely shuttered, the biotech struggled to quickly get clarity from the FDA on AR101's path forward.

An earlier-than-expected advisory committee date, though, gave analysts some hope for a speedier review.

Cantor Fitzgerald analyst Charles Duncan views the September meeting as a signal the FDA appreciates AR-101's potential value over current practices, as well as the burden of peanut allergies.

The advisory panel is expected to be a critical test for AR101 to clear.

RBC's MacKay anticipates committee experts will focus on the drug's impact on quality of life, particularly given a recent publication in The Lancet that argued against oral desensitization, emphasizing its risk for severe allergic reactions.

"The reality is that for children to avoid exposure to peanuts in today's world is extraordinarily hard," said Aimmune's Dallas. "If you're exposed to peanuts or peanut protein, the vast majority of folks in our study had no reaction after 12 months. Some of them had a mild reaction, very few of them had a moderate reaction, but none of them had a life-threatening anaphylactic reaction."

Dallas said he expects the panel to focus on the risks instead of efficacy, in particular rates of anaphylaxis and eosinophilic esophagitis. The exec said anaphylaxis rates were higher for patients not taking AR101 than those given the experimental therapy.

"This is the first time any of these treatments have come to the end of the day, and so folks will be looking into this," he said.

Regulatory delays aside, Dallas emphasized the end result rather than the timeline of AR101's review.

"Whether approval happens in September or October or November or December or January, a few months here and there I don't think makes a world of difference," Dallas said. "What is important is the review is fast, we come out of this with a great label, and we're able to offer this to the patients who need it."