Reprieve for Merck’s vorapaxar
pharmafile | January 16, 2014 | News story | Sales and Marketing | FDA, Merck, heart, vorapaxar
An FDA committee has voted that Merck’s troubled heart drug vorapaxar should be approved by the US regulator.
The advisory panel voted 10-1 in favour of the drug last night. If approved vorapaxar would be sold under the brand name Zontivity and would be licensed to reduce the risk of further heart problems in people who have suffered a recent heart attack.
Although the FDA is not bound to follow the advice of its advisory panels it typically does so, meaning Merck may be very close to an approval.
Panellists said that results from the latest TRA 2P trial were ‘robust’ and justified approval for patients who had suffered a heart attack.
But they agreed with the company that the drug should not be used in patients with a history of stroke, since there was an increased risk of bleeding in the brain in this group of patients.
Dr Daniel Bloomfield, who leads Merck’s cardiovascular research, said: “The results of [the] advisory committee mark an important milestone in our effort to bring vorapaxar to appropriate patients with a history of heart attack. We look forward to working with the FDA as it completes its review.”
But if approved the drug will sit within a growing new market which includes generic forms of Sanofi’s Plavix (clopidogrel), AstraZeneca’s Brilinta/Brilique (ticagrelor) and Lilly’s Effient (prasugrel).
Merck’s drug comes in pill form and is a novel PAR-1 antagonist that inhibits thrombin-induced platelet activation.
Safety concerns
But this seemed an almost impossible outcome two years ago after the blood thinner failed to meet its primary endpoint in a late-stage study.
The TRACER trial showed a non-significant 8% reduction in the first occurrence of heart attack, stroke, and recurrent ischemia. But more worryingly it also showed patients on vorapaxar had more serious bleeding events, including haemorrhagic stroke.
In all, 12 patients in the placebo group had such a stroke compared to 40 patients in the vorapaxar group.
A second TRA 2P study published in 2012, did see the drug pass its primary endpoint, but was again blighted by more safety issues after some patients saw a significant increase in bleeding, including intracranial haemorrhage.
The US firm has urged caution when prescribing the drug for patients who weigh less than 60 kilograms (132 lbs), since the risk of bleeding in these patients appears to be higher than in heavier patients.
Panellists could not reach a consensus recommendation on how lower-weight patients should be treated. Representatives from the FDA said they will continue to discuss the matter before making their final ruling.
Ben Adams
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