REUTERS: A high dose of Amarin Corp's Omega-3 drug Vascepa significantly reduced the occurrence of first and subsequent heart attacks, strokes and other serious heart problems in high-risk patients already taking cholesterol medication by even more than initially reported, according to data presented on Monday.
Compared with a placebo, Vascepa cut the combined rate of heart attacks, strokes, heart-related death, need for artery-clearing procedures and hospitalizations for unstable angina by 30 percent in heart disease patients at high risk for such events.
Amarin in September released initial results from the study of 8,179 patients already taking other heart drugs that showed a 25 percent reduction of serious heart events for those receiving a 4 gram dose of Vascepa compared with placebo, data that sent its share price surging from around US$3 to over US$12.
"With this drug, we are not only preventing that first heart attack but potentially the second stroke and maybe that third fatal event," Deepak Bhatt, the study's lead investigator from Brigham and Women's Hospital in Boston, said in a statement.
"Prevention of such subsequent cardiovascular events could improve patient outcomes and quality of life and may lower the total cost burden of medical care,” Bhatt added.
The data was presented at the American College of Cardiology scientific meeting in New Orleans.
Vascepa, a highly purified omega-3 fatty acid, a fat found in fish oil, originally won U.S. approval to treat patients with very high levels of triglycerides in their blood. Patients with high triglycerides who also have complications like diabetes are especially vulnerable to recurring cardiovascular complications.
Approval of an updated label for the pill that includes the heart protection data should significantly boost sales, and potentially pit Vascepa against the more expensive injectable cholesterol drugs Repatha from Amgen and Praluent from Regeneron Pharmaceuticals and Sanofi.
Analysts are forecasting 2019 Vascepa sales of more than US$350 million and climbing to US$1 billion by 2023, according to Refinitiv data.
A breakdown of the updated data shows Vascepa cut the rate of first heart events by 25 percent and second events by 32 percent. The incidence of a fourth or more events was reduced by 48 percent versus placebo.
In addition to statins to lower cholesterol, such as Pfizer's Lipitor, most of the patients in the study were also talking other heart drugs, such as blood pressure medicines or blood clot preventers.
(Reporting by Saumya Sibi Joseph in Bengaluru; editing by Bill Berkrot)