logo
Share SHARE
FONT-SIZE Plus   Neg

Merck Issues Update On Next Steps For TREDAPTIVE - Quick Facts

Merck (MRK), known as MSD outside of the United States and Canada, said it is taking actions to suspend the availability of TREDAPTIVE tablets globally. TREDAPTIVE is not approved for use in the U.S. These steps are taken based on the current understanding of the preliminary data from the Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events or HPS2-THRIVE study, and in consultation with regulatory authorities.

As reported earlier by the healthcare giant, HPS2-THRIVE failed to meet its primary endpoint of reduction of major vascular events, and there was a statistically significant increase in the incidence of some types of non-fatal serious adverse events in the group that received TREDAPTIVE compared with statin therapy. This suspension of availability of the medicine is aligned with the recommendation of the European Medicine Agency's Pharmacovigilance Risk Assessment Committee or PRAC, based on the study results.

In places where the medicine is currently available, Merck has started informing regulatory agencies of the company's decision. Merck is working with these agencies to develop communications for health care providers and to suspend the availability of TREDAPTIVE, with the timing to be based on individual country regulations and processes. Also, the healthcare giant is recommending that physicians stop prescribing TREDAPTIVE. Merck is also recommending that physicians review treatment plans for patients taking TREDAPTIVE in a timely manner to discontinue TREDAPTIVE and consider other changes in therapy to achieve their dyslipidemia management goals.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Bank of Nova Scotia or otherwise known as Scotiabank, Friday reported lower net profit for the third quarter, in the absence of a year-ago gain. Earnings per share, however, came in line with the Street view. Further, the company said it raised its quarterly dividend by 2 cents. Non-traditional discount and variety stores operator Big Lots Inc. (BIG) Friday reported a decline in net profit for the second quarter, while net sales grew 1.2 percent from the prior year. Comparable sales for the quarter increased 2.8 percent. Google has rejected the European Union's charges that it abused its market power and the demanded that it change the way it ranks online comparison shopping services in its search results, setting up a potentially long legal battle with the EU regulator empowered to levy billions of euros in fines
comments powered by Disqus
RELATED NEWS
Trade MRK now with 
Follow RTT