The stats on Phase III success rates aren't good. About half end in failure--and that's after developers have had a chance to do some careful testing in humans. It's no wonder, then, that...
New data on Merck's withdrawn cholesterol drug Tredaptive, a combination of niacin and an experimental drug laropiprant, shows that one-quarter of patients in a new trial withdrew because of side effects such as itching, rashes and muscle problems.
Two months ago Merck was forced to pull the plug on Tredaptive, a "good" cholesterol drug that foundered in a huge Phase III study after investigators tracked a number of nonfatal adverse events among the people taking the treatment, a combination of extended-release niacin and an experimental antiflushing drug called laropiprant. Initially, Merck didn't spell out the adverse events.
Merck is in a world of hurt. The pharma giant managed to spook several analysts with the news that its osteoporosis drug odanacatib would be held back from regulators until more data could be obtained in a trial extension, raising fears that the badly needed drug may be about to jump the tracks.
Merck CEO Kenneth C. Frazier today had to give shareholders the bad news and then he had to follow that up with the really bad news.
Merck is pulling the plug on Tredaptive, its once ambitious drug for raising good cholesterol, which the company acknowledged turned out to be generally ineffective and to have elevated health risks.
Regulators in Europe have had an "aha" moment about Tredaptive.
Just hours after Merck spelled out that its one-time blockbuster hopeful Tredaptive had failed a huge late-stage study with more than 25,000 patients, the EMA stepped in to call for a quick review of a cholesterol drug that is currently being sold in several countries on the continent.
Merck's late-stage development effort suffered a major setback today as investigators announced that its huge Phase III trial of the "good" cholesterol drug Tredaptive--extended-release niacin/laropiprant--flunked its primary endpoint.
Just three months after quietly snuffing its late-stage development program for the cholesterol combo MK-0524B, Merck has once again quietly doused development efforts on a new cholesterol therapy. MK-0431E, once in line for a 2014 regulatory filing, was killed for unspecified business reasons, according to Dow Jones.