FDA and EMA join forces to diffuse safety cloud over Januvia, Victoza & Co.

FDA

Merck's ($MRK) Januvia, Novo Nordisk's ($NVO) Victoza and their brethren are in the clear. After a new round of safety reviews, U.S. and European regulators found little evidence that widely used diabetes drugs known as incretin mimetics cause pancreatitis or pancreatic cancer.

The decision, published by the FDA and the European Medicines Agency Thursday in The New England Journal of Medicine, is the latest vindication for two drug classes, GLP-1 agonists and DPP-4 inhibitors. The agencies said suggestions that the drugs could cause pancreatic disease are "inconsistent with current data."

The agencies both launched safety reviews last year after newly released studies flagged pancreatic problems in patients using the drugs. Besides Januvia and Victoza, the group includes AstraZeneca's ($AZN) Onglyza, Takeda's Nesina, and Eli Lilly ($LLY) and Boehringer Ingelheim's Tradjenta, which are DPP-4 inhibitors. It also comprises AstraZeneca's Byetta and Bydureon, both GLP-1 drugs.

The FDA's Dr. Amy G. Egan, the NEJM article's lead author, told The New York Times that the two agencies decided to share their data and work together on a joint publication because of "intense interest" in their findings. Safety worries had haunted the drugs and may have been a factor in slowing Januvia sales, analysts have said.

Critics maintain that the drugs are indeed risky and question the agencies' decision process. A researcher who repeatedly sounded the alarm on pancreatitis and cancer risks, Dr. Peter C. Butler of the University of California, Los Angeles, called for the analyses to be made public, the Times reports. The FDA and EMA announcements provide "very little information as to how they reached this conclusion," Butler told the NYT.

Public Citizen's Dr. Sidney Wolfe, a longtime drug watchdog, also criticized the review's outcome, saying it gives "false assurances of safety." Public Citizen petitioned FDA in 2012 to pull Victoza from the market and failed.

As the Associated Press points out, the agencies have left themselves some wiggle room. The review "provides reassurance" to doctors and patients, the NEJM article states, but the FDA and the EMA "have not reached a final conclusion" about whether the drugs can trigger pancreatic problems. They'll continue to investigate, the study authors wrote.

- see the NYT coverage
- read the NEJM article

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