FDA deals Merck two R&D setbacks with pair of CRLs

Merck ($MRK) has hit bumps in the road toward desired FDA approvals of its drugs MK-8175A, an oral contraceptive, and the ophthalmic drug tafluprost. The FDA sent the U.S. drug giant a pair of complete response letters over the past week concerning applications for those meds. The company opted not to reveal the bad news in press releases, deciding instead to tuck them deep into a quarterly earnings filing with the SEC. Pharmalot's Ed Silverman dug them up and gave Merck a good lashing for its chosen means of disclosure.

The exact details on the two CRLs are hazy, as Merck doesn't provide any reasons why U.S. regulators decided not to approve its applications. According to the SEC filing, the company plans to meet with regulators to chat about both of the CRLs. The company's MK-8175A or NOMAC/E2 is already green-lighted for the market in the European Union, where it's sold under the brand name Zoely. As for tafluprost, Merck has been seeking approval for the drug, which it licensed from Santen Pharmaceutical, as a treatment for open-angle glaucoma (a.k.a. ocular hypertension).

A press release explaining these CRLs might have shed light on what hurdles these programs face to get FDA approval. Pharmalot characterized Merck's decision to bury the CRL disclosures in an SEC filing without issuing a press release as irregular. And the obvious setback of the CRLs is probably not the kind of Merck wanted ahead of its big annual R&D meeting for investor types. But now the drug giant's executives might find themselves fielding questions about these applications that the FDA didn't want to approve during the meeting.

- get more in Silverman's post
- here's the SEC filing

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