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Merck Statement Regarding CHMP Review Of Incretin-Based Therapies For Type 2 Diabetes, Including Sitagliptin

Stock quotes in this article: MRK

Merck, known as MSD outside the United States and Canada, issued the following statement regarding the conclusion of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) review of GLP-1, or incretin-based, therapies, including sitagliptin. The EMA issued a news release today, “Investigation into GLP-1 based diabetes therapies concluded: No new concerns for GLP-1 therapies identified on the basis of available evidence.” The EMA’s full news release is available here.

“Nothing is more important to us than the safety of our medicines and the people who take them. We appreciate the important role that the EMA and its CHMP play in monitoring the safety of medicines in Europe,” said Michael Rosenblatt, M.D., executive vice president and chief medical officer, Merck. “We are confident in the safety profile of sitagliptin, an important medicine to help adults with type 2 diabetes lower their blood sugar levels.”

Earlier this year, the U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication on incretin-based drugs, including sitagliptin. The statement indicated that the FDA has not reached any new conclusions about safety risks with incretin mimetic drugs, and recommended that patients continue to take their medicine as directed until they talk to their health care professional, and that health care professionals continue to follow the prescribing recommendations in the drug labels. The FDA said “it will communicate its final conclusions and recommendations when its review is complete or when the Agency has additional information to report.”

The American Diabetes Association (ADA), the European Association for the Study of Diabetes (EASD) and the International Diabetes Federation (IDF) said that they have reviewed the data available to date and found that there is insufficient information to modify current treatment recommendations. On June 28, the three organizations issued a joint statement, which is available here.

“The efficacy and safety profile of sitagliptin supports its use in a wide range of adult patients with type 2 diabetes,” Rosenblatt said. “We will continue to monitor the safety of sitagliptin in close collaboration with regulatory agencies and scientific experts.”

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