FDA has approved Merck Sharp & Dohme's Zontivity. It reduces the risk of heart attacks and strokes by preventing blood clots.
Heart attacks and strokes are responsible for every one in 4 deaths in the United States each year. Heart diseases are also touted to be the leading cause of death in the country, claiming over 600,000 million lives annually. These numbers have experienced a significant rise in the last few decades.
The FDA has approved a drug that has the potential of reducing the risks of heart diseases, strokes and artery blockage. Zontivity tablets belong to a new class of drug, called a protease-activated receptor-1 (PAR-1) antagonist. It has the ability to reduce the tendency of blood platelets to clump together to form a blood clot. This in turn, reduces the risk of blockages in the arteries to the legs and helps restore normal blood flow to the heart in patients with a previous heart attack.
"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 percent to 7.9 percent over a 3-year period - about 0.5 percent per year," said Ellis Unger, M.D., director of the Office of Drug Evaluation I in the FDA's Center for Drug Evaluation and Research in a statement.
The efficacy of the drug was tested in a clinical trial involving over 25,000 individuals. Researchers found that when the participants were given Zontivity along with another anti-platelets agent (aspirin and clopidogrel), they were at a reduced risk of heart attack, stroke, cardiovascular death compared to participants that were given a placebo. Researchers also noted that patients treated with Zontivity didn't require any urgent procedure to improve blood flow to the heart during a heart attack.
FDA officials point out that the medication is more effective for high-risk patients. They also warn that the drug should not be used by patients who have had a stroke, transient ischemic attack (TIA), or bleeding in the head.
The administrative body also clarified that prescribing physicians should also warn patients that they may get bruised and bleed more easily when consuming Zontivity. Any prolonged or excessive bleeding, including blood in stool should be brought to a doctor's attention immediately.
