With recent notices of 'deficiencies,' the FDA may be 'raising the regulatory bar': analyst

In dinging Myovant and Pfizer’s endometriosis application for Myfembree earlier this week, the FDA used language that has become increasingly familiar. In a notice, the companies said the agency cited “deficiencies that preclude discussion of labeling and/or post-marketing requirements and commitments at this time.”

While this bit of gobbledygook may be a challenge to translate, analysts at Evercore ISI are starting to make some sense of it.

They’ve noted that of the 14 cases they found where companies have reported receiving such a notice ahead of an FDA decision date, more than half have happened within the last year. It’s an indication that the regulator is tightening the screws on approvals, the Evercore ISI team believes.

“Overall, these deficiencies contribute to the view that the FDA is raising the regulatory bar,” analyst Josh Schimmer wrote in a note to clients.

Of the 14 such notifications, 11 eventually resulted in complete response letters, the analyst pointed out. The other three—including Myovant and Pfizer’s bid for Myfembree in endometriosis—have yet to be resolved.






But receiving a “deficiencies” notice is hardly a death sentence for a drug. Of the 14 companies notified, Antares and TherapeuticsMD worked to gain approvals, while several others have new target dates set for this year.  

Also working to fix “deficiencies” are Axsome Therapeutics, which received its notification in August of last year on its depression candidate, and Spero Therapeutics, which heard from the FDA two weeks ago on its urinary tract infection treatment tebipenem.

Spero’s alert was conspicuous, Evercore notes, because it came well ahead of the application’s target date of June 27. Of the 13 other “deficiencies” notices, all but one came within a month of the agency's decision date. Pfizer and Myovant’s date, for example, was May 6.

Another company that received early notice of “deficiencies” was Provention Bio, which heard from the FDA in April of last year, three months ahead of its target date for its type 1 diabetes drug teplizumab. When the date arrived, Provention got its complete response letter.






As for the companies still in limbo with their applications, Evercore believes that Axsome’s nod is “likely,” and Spero’s could come within one year. Myovant and Pfizer’s issues “should be workable given Myfembree is already on the market,” Schimmer wrote.