A year after the FDA handed TherapeuticsMD $TXMD a rejection letter for its therapy preventing vaginal pain during sex, the agency has done a complete 180 — approving the treatment after waving off the safety concerns that had once warranted a CRL.
The decision to drop the CRL and allow the application to proceed without meeting specified hurdles is one of three the FDA executed in the weeks after Scott Gottlieb jumped into the top job at the FDA, raising concerns that political influence was changing the fortunes of some of the companies with business before the agency. In this case, Gottlieb — handed a mandate to speed approvals — won the nomination the day after the rejection was announced by TherapeuticsMD.
Two other companies also earned a reprieve under Gottlieb: Amicus, where CEO John Crowley had lobbied officials claiming that their rejection of its experimental Fabry drug migalastat would delay it by 5 to 7 years, far more than the 2 years he told shareholders; and Eli Lilly, which recently won over an expert panel on a questionable low dose of baricitinib.
In Amicus’ case, the FDA put the drug on the agency’s inside track, offering a fast priority review ahead of an expected approval.
In this case, TherapeuticsMD — which is chaired by ex-HHS secretary Tommy Thompson, who ran a group of prominent Bush administration Republicans backing Donald Trump for president — told investors last year that the agency had flagged concerns about the absence of safety data beyond the 12-week stretch tested in the clinic. It also didn’t help initially that there are other products for the condition, lessening the urgency of an approval.
The agency doesn’t publish CRLs and never offered an explanation for its reversal, an agency standard on individual companies.
Their estradiol vaginal inserts will be sold as Imvexxy.
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