Five months after Merck's woeful application for ridaforolimus was shown the door at the FDA, the Europeans repeated the regulatory coup de grace on the other side of the Atlantic.
In pulling its application for ridaforolimus, Merck ($MRK) acknowledged the view of the EMA's Committee for Medicinal Products for Human Use: "That the data available to date and provided in the Marketing Authorization Application were not sufficient to permit licensure of ridaforolimus in the European Union for the maintenance treatment of patients with soft tissue sarcoma or primary malignant bone tumor."
That's essentially the same conclusion the FDA came to last summer. The FDA staff review raised serious concerns about exposing patients to the side effects of the drug while offering just a few weeks of added progression-free survival. And the agency's panel of experts gave a thumbs-down on the application by a lopsided 13-to-one vote against approval.
For Merck, the ridaforolimus failure represents the latest in a series of late-stage pratfalls. But Merck, which licensed the drug from Ariad ($ARIA), insists that it hasn't given up on the drug. Its investigators have been beavering away at other studies investigating its usefulness in other tumor types. It's also been talking up the prospects of the sleep drug suvorexant, which hopes to compete for a shrinking market with a new drug with a better safety profile.
For Ariad's part, the biotech company has been focused entirely on ponatinib, which is up for approval in the U.S. and Europe. Unlike ridaforolimus, ponatinib is given good odds for success in the U.S. and Europe, where Ariad says it will handle the drug launch on its own.
- here's the press release