Merck (MRK: Quote), 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.
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by RTT Staff Writer
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