Aimmune faces crucial FDA panel vote on first peanut allergy drug | BioPharma Dive

Dive Brief:

• Friday the 13th is slated to be a consequential day for Aimmune Therapeutics, as a panel of experts convened by the Food and Drug Administration will vote on whether to recommend the biotech's peanut allergy treatment.
• Wall Street analysts widely expect panelists to support approval, but some also anticipate the advisory committee to debate lingering safety questions. The FDA isn't required to follow the advice of its expert panels, but usually does.
• After listening to presentations from the company, food allergy experts, FDA reviewers and the public, the committee is scheduled to discuss and vote on the FDA's questions by 4:30 p.m.

Dive Insight:

Advisory committee recommendations can guide the FDA's regulatory decisions. In this case, the agency is expected to make its call by January 2020 on Aimmune's drug, which could be the first immunotherapy to reach market for the most common food allergy in the U.S.

Consisting of defatted peanut flour, AR101, as the drug's called, is designed to desensitize patients allergic to peanuts over time.

Briefing documents prepared by FDA staff suggest Friday's discussion will focus on AR101's safety profile. The documents were consistent with how Aimmune has interpreted its own data, said Stephen Tilles, Aimmune's senior director of medical affairs, in an interview Thursday.

Specifically, agency staff focused on the fact that patients treated with the immunotherapy had higher rates of systemic allergic reactions than those in placebo groups. Additionally, 12 patients treated with AR101 were diagnosed with an allergic inflammatory disease called eosinophilic esophagitis, compared to none given placebo.

Tilles said the frequency of those allergic reactions decreased as treatment continued, and 98% of those events were mild or moderate. He added the 12 cases of the inflammatory disease resolved after stopping treatment, characterizing it as a "transient phenomenon as long as you withdraw treatment."

Analysts anticipate Aimmune's drug could receive a black box warning label, as have all previously approved oral allergen extracts, RBC Capital Markets analyst Kennen MacKay wrote in a research note.

The black box is "a cost of doing business in the allergy product field," MacKay wrote. Four sublingual immunotherapies that treat allergies such as grass pollen, dust and ragweed pollen all carry similar warnings.

Tilles said a black box wouldn't alter Aimmune's plans for the drug, which the company doesn't consider an extract.

Even before the panel votes, Aimmune has begun to lay out its commercial plans. If approved, AR101 would be sold as Palforzia. The biotech is seeking an initial label for children ages four to 17 to reduce the frequency and severity of allergic reactions to peanuts.

A bigger question will be price. In a newly updated corporate presentation, it appears Aimmune's list price could exceed the cost-effectiveness range set earlier this year by ICER, an influential nonprofit that assesses drug prices.

ICER recommended a pricing range of $4,800 to $7,200 per year. Aimmune is considering a price more expensive than sublingual immunotherapies, which cost about $3,000 to $5,000, and below infused asthma biologics, which the biotech pegged at $20,000, according to its presentation.

Aimmune plans to initially focus on 1,300 allergists in 800 clinics that treat a majority of peanut allergy patients. The biotech expects annual sales of Palforzia to grow to more than $1 billion over time.

Aimmune's stock has increased about 15% since Monday in the build-up to Friday's meeting.