Merck to seek approval for Vorapaxar, Tredaptive in 2013

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Merck will seek regulatory approval of two cardiovascular drugs in the U.S. and Europe, the company announced Aug. 26 at the European Society of Cardiology  Congress in Munich. The drugs are a thrombin receptor antagonist (Vorapaxar) and extended release niacin/laropirprant (Tredaptive), the latter of which is designed to reduce high-density lipoprotein cholesterol.

Merck said it would file applications for Vorapaxar in the U.S. and Europe in 2013 for an indication for the prevention of cardiovascular events in patients with a history of heart attacks and no history of transient ischemic attack or stroke. At ACC.12, results from TRA-2P-TIMI 50 (Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombosis) showed an almost 20 percent reduction in cardiovascular events in MI patients who received once daily 2.5 mg dose of Vorapaxar with aspirin for diagnosed atherosclerosis (heart attack, stroke or peripheral artery disease) compared with placebo. Overall, cardiovascular death or MI occurred in 7.3 percent in the Vorapaxar group vs. 8.2 percent in the placebo group.

But rates of bleeding were highest in patients with a previous incidence of stroke. In January 2011, the study’s data monitoring and safety board advised that stroke patients discontinue study participation due to the heightened rate of intracranial hemorrhage found within the vorapaxar group.

In a different patient population—those with acute coronary syndrome—Vorapaxar added to standard therapy failed to significantly improve outcomes and increased the risk of major bleeding, including intracranial hemorrhage.

Merck also set a date of 2013 to file applications in the U.S. and in Europe for the cholesterol drug MK-524A (Tredaptive). It reported that the HPS2-THRIVE (Treatment of HDL to Reduce the Incidence of Vascular Events) study is expected to be completed this year.

The Whitehouse Station, N.J.-based company also provided an update on MK-0859 (anacetrapib), an investigational drug under development to treat hypercholesterolemia and prevent cardiovascular disease. The target date for completion of clinical trials is 2017.