FDA: Vytorin 'unlikely' to boost cancer risk

It's been a good news-bad news kind of week for Merck and its cholesterol drugs Vytorin and Zetia. First, the good news: FDA says it has finished reviewing the data on potential links between those drugs and an increased risk of cancer and cancer-related deaths. And on balance, it's "unlikely" that the drugs increase those risks, the agency says.

"Based on the currently available information, FDA believes it is unlikely that Vytorin or Zetia increase the risk of cancer or cancer-related death, but at this time an association cannot be definitively ruled out," the agency said (as quoted by the Wall Street Journal).

Now, the bad news: Just a couple months after finalizing its purchase of Schering-Plough--and with it, full control of both Vytorin and Zetia--Merck now has to fight off a patent challenge. Merck's Schering unit brought suit after Mylan became the first to ask FDA to approve its generic version of Vytorin. In fact, Schering sued twice: Once in West Virginia, where Mylan is based (in Morgantown, FYI), and once in New Jersey, where Schering has its HQ.

Merck's cholesterol-drug woes have been in the news a lot this year: The studies that questioned the meds' efficacy, outcomes-wise if not surrogate-marker-wise; the subsequent decline in scrips and sales. But the FDA's decision on cancer risk removes at least part of the worry. And by any measure, Vytorin and Zetia together are big-time revenue drivers for Merck. We'll have to wait and see whether the FDA judgment translates into better sales numbers.

- see the WSJ story
- get more from the WSJ Health
- read the Bloomberg piece

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