A couple pieces of news today on Merck’s big cholesterol drug Vytorin, which has seen its share of trouble in the past couple years but remains widely prescribed:
The FDA said it’s “unlikely” that Vytorin or Zetia, another Merck drug, increase the risk of cancer. But “an association cannot be definitively ruled out,” the agency said. Vytorin is a combination of two drugs — Zetia and a statin called simvastatin. It’s clear that simvastatin doesn’t raise cancer risk, the FDA said, but there’s not enough data to “definitively rule out” a cancer link for Zetia (known generically as ezetimibe).
The uncertainty comes from a study that found there were more cancers and cancer-related deaths in patients who took Vytorin, compared with those who received placebo. But other studies of the drug have not shown similar risk. Animal studies have not shown a cancer link. And the cancer risk found in the study came from combining several types of cancer together. “It is biologically less likely that a single drug increases the risk of a wide variety of cancer types,” the FDA said.
Mylan, a big generics shop, said it had been sued by a Merck subsidiary for patent infringement because it applied to sell a generic version of Vytorin.
This is is the kind of lawsuit generic drug makers wear like a badge of honor these days. In its statement today, Mylan said it believes it is the first generic company to file this sort of application for Vytorin; if the company is correct, it will get a six-month window during which it’s the only generics company allowed to compete against Merck for sales of the drug.
An exclusivity period on a big drug like Vytorin — and it’s still a very big drug, despite the troubles it’s had — means a windfall for a company like Mylan.