A Federal Drug Administration advisory panel of experts has recommended that Merck's antiplatelet drug vorapaxar be approved for use as add-on therapy in patients with a history of heart attack.
The Federal Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee has recommended approval of Merck’s vorapaxar. The drug, which will be marketed under the brand name Zontivity, is the company’s first investigational antiplatelet medicine for the reduction of atherothrombotic events, for patients with a history of heart attack and no history of stroke or transient ischemic attack. While the advisory committee does not dictate to the FDA, its review will be taken into consideration for final approval of vorapaxar by the FDA.
“There are approximately 7.6 million Americans who have survived a heart attack. Each year, about 190,000 of them have a recurrent heart attack, so there remains a need for additional treatment options,” Daniel Bloomfield, MD, vice president, Cardiovascular Diseases, Merck Research Laboratories, said in a statement. “The results of today’s 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.”
Vorapaxar is a protease-activated receptor-1 (PAR-1) antagonist designed to prevent heart attacks and blood clots in at-risk patients. PAR-1 is a receptor activated by thrombin, known to be a potent platelet activator. Vorapaxar would inhibit thrombin-induced platelet aggregation by blocking PAR-1 receptors on platelets. If final approval is granted by the FDA, vorapaxar will be used as additional therapy with other common blood thinners, such as aspirin.
Despite serious side effects including internal bleeding, the AP reported the Committee voted 10-1 in favor of approving the drug. “I think this drug addresses an important unmet need and can make a real difference for patients,” said Philip Sager, MD, of Stanford University, who chaired the panel.