Merck’s vorapaxar gains long-awaited FDA approval
pharmafile | May 9, 2014 | News story | Sales and Marketing | Boehringer, FDA, Merck, lilly, vorapaxar, zontivity
Merck’s heart drug vorapaxar has finally been given the FDA go-ahead after looking dead in the water less than two and a half years ago.
The pill which is to be marketed as Zontivity, can now be used by patients with a history of heart attacks to improve blood flow to the organ and prevent further cardiovascular events.
The US regulator’s decision represents a major reversal in fortunes for Merck’s treatment. In 2011, the drug failed a late-stage trial which appeared to link it with dangerous bleeding and stroke.
In the study, patients taking the pill were found to be three times more likely to have a stroke than those on a placebo. However, analysis of a second trial identified a subgroup of participants that appeared to benefit from the treatment – and those results form the basis of the FDA’s latest decision.
Expanding on the evidence, Ellis Unger of the regulator’s Center for Drug Evaluation and Research says: “In patients who have had a heart attack or who have peripheral arterial disease, this drug will lower the risk of heart attack, stroke, and cardiovascular death.
“In the study that supported the drug’s approval, Zontivity lowered this risk from 9.5% to 7.9% over a three-year period – about 0.5% per year.”
The drug remains unapproved for patients with a history of stroke, transient ischemic attack or bleeding in the head as it poses the risk of causing further bleeding.
Merck has also preached caution against patients weighing less than 60kg taking the drug, although the FDA’s official approval announcement does not make any reference to this concern.
Vorapaxar is part of a new class of drugs called PAR-1 antagonists. It works by preventing blood platelets from clumping together, reducing the risk of dangerous blood clots forming.
The drug enters a busy market with rival products Effient (prasugrel, Lilly) and Brilinta (ticagrelor, AstraZeneca) already firmly established in the US – as well as cheaper, generic forms of Sanofi’s Plavix (clopidogrel).
Writing on his firm’s blog, Conor Walsh of global healthcare consultancy Decision Resources suggests that vorapaxar’s earlier, worrying trial results will ‘narrow its market opportunity’. He predicts a ‘modest market opportunity’ for the drug.
Hugh McCafferty
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