Fate of Merck’s vorapaxar still unclear
pharmafile | February 8, 2012 | News story | Medical Communications, Sales and Marketing | Merck, vorapaxar
Merck & Co’s blood thinner vorapaxar, designed to prevent blood clots and reduce heart attacks, is still causing bleeding in patients.
Data from a new study of the oral protease activated receptor 1 (PAR-1) thrombin receptor antagonist, there is a significant increase in bleeding, including intracranial hemorrhage (ICH), among those taking it with standard of care.
Despite this, the TRA-2P study actually met its primary endpoint – reducing the risk of cardiovascular death, heart attack or stroke compared to standard of care. There was also a lower risk of ICH in patients without a history of stroke.
Merck has only released general information from its latest trial, with the promise of detailed data to follow next month at the scientific sessions of the American College of Cardiology.
Vorapaxar, developed for the prevention of thrombosis and the reduction of cardiovascular events, had been seen as a potential blockbuster – but its progress has already been clouded by the bleeding issue.
There must still be significant doubts about the drug’s future. Reuters quotes ISI Group analyst Mark Schoenebaum as pointing out: “We do not yet know the magnitude of the efficacy nor the bleeding risk in these patients.
“In developing vorapaxar, Merck and our scientific collaborators set a very high bar – would the addition of vorapaxar to standard of care provide incremental benefit in preventing clots?” said Peter S. Kim, president of Merck Research Laboratories.
“We are pleased that TRA-2P met its primary endpoint, and we look forward to discussing the results with the scientific community,” he added.
Despite this upbeat assessment, the new results must be the source of worried head-scratching at Merck: the company says it will be getting the opinion of “external experts” on the data from TRA-2P and the earlier TRACER trial before deciding on the next steps.
TRACER compared vorapaxar plus standard of care to placebo plus standard of care in patients with acute coronary syndrome.
While there was a non-significant 8% reduction in the first occurrence of heart attack, stroke, and recurrent ischemia, the trial also showed patients on vorapaxar had more serious bleeding events, including haemorrhagic stroke.
Twelve patients in the placebo group had such a stroke compared to 40 patients in the vorapaxar group.
And an earlier trial had showed it caused excess bleeding in patients who had already suffered a heart attack or stroke and were at risk of further cardiovascular problems.
Adam Hill
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