EXOME

all the information, none of the junk | biotech • healthcare • life sciences

FDA’s Gottlieb Adds Confusion to Aimmune’s Claims of Shutdown Delay

Xconomy San Francisco — 

The first biotech company to cite the partial government shutdown as a reason for serious delay was Aimmune Therapeutics (NASDAQ: AIMT), as Xconomy reported Tuesday. The announcement, however, soon raised more questions than answers.

Aimmune reported in a regulatory filing Tuesday that the FDA would not start reviewing its peanut-allergy treatment, AR101, because of the shutdown.

The disclosure sparked what seemed to be a rebuke from FDA commissioner Scott Gottlieb. The social-media savvy commish took to Twitter and, without naming Aimmune directly, noted that companies sometimes seek product approvals “under pathways that aren’t open to them.” He also warned of “some parties who are using the excuse of the shutdown to advance misleading narratives.”

The implication: Brisbane, CA-based Aimmune was blaming the FDA, and the shutdown, when perhaps it misunderstood how the FDA was characterizing its drug, AR101. Gottlieb noted that blood products and allergenic “extracts” were in a review group that had run out of money, while reviews for other types of drugs, like pills and biologics, still have a few weeks of funding left from 2018. That funding comes from the fees that drug owners pay to the FDA. (This road to approval for a prescription medicine is known as the PDUFA pathway.)

Aimmune spokeswoman Alison Marquiss told Xconomy Wednesday that the company, which said publicly in December and again last week that it has paid PDUFA fees for AR101, was confused about Gottlieb’s comments. “Our product is not an extract… it’s a complex biologic drug,” she said. (According to the official clinical record, AR-101 is peanut protein provided to patients in capsules and sachets. The idea is to give patients increasing doses over 12 months to desensitize them.)

Aimmune is “seeking clarification from the FDA,” she said, but as of Thursday afternoon had not received clarification about its status or Gottlieb’s comments from the agency. Marquiss said if not for the shutdown, Aimmune was getting ready for—in a best-case scenario—an early fall approval and launch.

When pressed on Twitter about his comments, Gottlieb asked reporters to check with the FDA’s media office: “We’re here to answer inquiries from press and working hard to communicate.”

A first round of queries to the press officers who specialize in drug review questions triggered an auto-reply, which said that requests are being triaged because of the shutdown.

With more prompting, the office’s director, Sarah Peddicord, sent this note Wednesday: “We don’t have any more to share at this time.”

Aimmune submitted its approval application on Dec. 21, the day before the shutdown. Just a day earlier, DBV Technologies (NASDAQ: DBVT) withdrew an application for a rival peanut allergy treatment, though it plans to file a new one in the future. Aimmune shares closed at $22.61 Thursday, down around 10 percent since the disclosure of the delay.

Ben Fidler contributed to this report.