New Antiplatelet Agent Approved
FDA on May 8 announced the approval of vorapaxar oral tablets, in conjunction with aspirin or clopidogrel, to reduce the risk of thrombotic cardiovascular events in patients with peripheral arterial disease or a history of myocardial infarction.
Vorapaxar, a protease-activated receptor-1 antagonist, will be marketed as Zontivity by Merck. The company stated that the product will be available during the third quarter of this year.
According to FDA, vorapaxar is the first drug in its class approved by the agency.
According to the labeling (PDF) for vorapaxar, the drug inhibits thrombin-induced and thrombin receptor agonist peptide-induced platelet aggregation in in vitro studies.
In placebo-controlled clinical trials, vorapaxar, in combination with aspirin or clopidogrel, reduced the combined risk of heart attack, stroke, cardiovascular death, and the need for acute coronary revascularization.
A boxed warning and an FDA-required Medication Guide (PDF) for vorapaxar alert patients and prescribers to the risk of serious bleeding associated with the drug and other antiplatelet agents.
Bleeding was the most frequently reported adverse event associated with vorapaxar-containing antithrombotic regimens studied in clinical trials. No drug is known to reduce the antiplatelet effects of vorapaxar. Because of the drug's long half-life, the antiplatelet effects persists for weeks after discontinuation of vorapaxar, the drug's labeling states.
Patients who have active pathological bleeding or a history of stroke, transient ischemic attack, or intracranial hemorrhage must not use vorapaxar.
The recommended dosage of vorapaxar is one 2.08-mg tablet taken once daily, with or without food. The drug has not been studied as a standalone antiplatelet agent and should be used in combination with aspirin or clopidogrel.
Vorapaxar will be packaged in bottles of 30 and 90 2.08-mg tablets each and in 100-tablet unit-dose packages consisting of 10 10-tablet blister cards. The drug should be stored at controlled room temperature.