This Day On The Street
Continue to site
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

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

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.”

1 of 6

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
SYM TRADE IT LAST %CHG

Markets

DOW 17,757.91 +138.40 0.79%
S&P 500 2,077.42 +14.31 0.69%
NASDAQ 5,013.1230 +26.2560 0.53%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs