FDA, Politics, Regulatory

Aimmune says US government shutdown stymied its peanut allergy drug application

As the longest government shutdown in US history endures the wrath of lawmakers on either side of the aisle, Aimmune Therapeutics $AIMT will bear the brunt of stretched funds at the FDA. Company management — who submitted their application to market their peanut allergy drug one day preceding the shutdown — on Monday said the health regulator had notified them that it would not be able to review the application until the lapse in appropriations ends.

Aimmune’s arch rival DBV Technologies $DBVT said it had rescinded an application to market its peanut allergy patch on December 20, after the FDA expressed concern about the state of manufacturing and quality control data submitted. The following day, Aimmune submitted its application for peanut allergy immunotherapy AR101, in effect leapfrogging its competition for a first-mover shot at capturing the so far untapped market, which is expected to grow to $4.5 billion in 2027 globally, according to GlobalData. The US shutdown began on December 22 — after President Trump insisted on $5.7 billion from Congress to build a wall on the southwest US border.

In a series of tweets on Monday, FDA commissioner Scott Gottlieb suggested that applications submitted prior to the shutdown would be reviewed, but that the agency was unable to accept user-fees to review any medical products over the course of the lapse. Clarifying the FDA’s position further, he tweeted later in the day that blood products and allergenic products are not covered by user fee programs, hinting that Aimmune may have submitted its application under the wrong pathway.

“Though this announcement does set back the potential approval of AR101…any delay will, at worst, last as long as the shutdown but believe that the breakthrough designation and unmet need could result in FDA accelerating a review timeline to remain, more or less, in line with expectations for a 3Q19 approval,” Baird’s Brian Skorney wrote in a note.

Meanwhile, data from a European Phase III trial evaluating AR101 are expected in the first quarter of 2019.

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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