Can fish oil help prevent, or reduce the risk of heart disease? Several studies have failed to show that it can. But Amarin this morning is releasing data from a massive study showing that its prescription-grade fish oil pill, Vascepa, has done that—at least for some patients.
Amarin (NASDAQ: AMRN), of Bedminster, NJ, and Dublin, said today that a 8,179-patient clinical trial called REDUCE-IT has succeeded. Vascepa lowered the risk of heart attacks and strokes in patients with very high levels of triglycerides—a type of fat in the blood—and whose cholesterol levels were already held in check by drugs called statins. Patients on Vascepa had a 25 percent reduction in the relative risk of a heart attack, stroke, cardiovascular death, or hospitalization for unstable angina or bypass surgery after a median of 4.9 years of treatment, compared to those on statins and a placebo. The drug’s safety profile was similar to that of other omega-3 fatty acids, Amarin says.
To be clear, Amarin is only releasing a glimpse of the results from the study. Critical details, like subgroup analyses, the drug’s effects on over 30 other measures, and granular safety information, will be presented at a medical meeting in November. Nonetheless, primary investigator Norman Lepor, a cardiologist at Cedars-Sinai Heart Institute and professor of medicine at UCLA, says the data are a “game-changer.”
“The results will impact how I treat patients starting tomorrow,” Lepor says.
Shares of Amarin boomed 307 percent in pre-market trading on Monday morning, to $12.17 apiece.
Despite the widespread use of statins—some 40 million Americans take them—heart disease remains the leading cause of death, according to the Centers for Disease Control and Prevention. Many patients still can’t control their cholesterol or triglyceride levels, or suffer heart attacks despite treatment. For years, drugmakers have tried to show that adding fish oil to the mix can help because it can lower triglycerides, a risk factor for heart disease. But several clinical studies have failed to prove the worth of fish oil. Just last month, for instance, an independent academic group based in the U.K. released its own fish-oil study, dubbed ASCEND. The ASCEND study showed that a 1 gram dose of a generic capsule had no favorable outcome for patients. Lepor says he has rarely used Vascepa and fish oils in general in practice because the evidence wasn’t there to support their role in treating heart disease.
Christie Ballantyne, the chief of cardiology at Baylor College of Medicine (who has gotten research support from Amarin and sits on the REDUCE-IT steering committee), notes that REDUCE-IT is “very different” from the prior studies, including ASCEND, that have failed. Among the differences: the focus on only high-risk patients tested in Amarin’s study; REDUCE-IT’s higher dose of 4 grams, and Vascepa’s different composition. Patients in the REDUCE-IT study had higher triglyceride levels—between 150 and 499 mg per deciliter of blood—and other cardiovascular risk factors, like diabetes. And Vascepa is pure eicosapentaenoic acid (EPA), while the ASCEND study, for one, used a mix of EPA and a different omega-3 fatty acid, docosahexaenoic acid.
Indeed, Lepor says the REDUCE-IT results confirm that Vascepa has “unique characteristics that will not allow me to extrapolate the results from this trial” to other prescribed or over-the-counter fish oils. Lepor now plans to use the Amarin drug in his patients on statins with controlled cholesterol but high triglyceride levels and a history of heart problems or diabetes.
Amarin has been counting on results like these. The company began accruing patients for the REDUCE-IT study in November 2011. It won FDA approval of Vascepa in March 2012 for patients with very high triglyceride levels—more than 500 mg per deciliter of blood. But that approval did not give Amarin the right to market the drug more broadly or claim that Vascepa would improve health outcomes. That might seem odd, but in some disease areas, the FDA will approve drugs, if relatively safe, that affect a marker of a disease because of a long association between the marker and health outcomes.
But the agency, and more importantly, doctors who might prescribe the drug, will also expect further studies to show more than an association. Vascepa sales have grown steadily—they climbed from about $50 million in 2014 to $180 million in 2017. But the drug has never taken off, in part because Amarin hasn’t had the proof that the drug can prevent heart disease, something that would set its fish oil pill apart from rival prescription-grade fish oils (Lovaza, from AstraZeneca) or over-the-counter supplements. Amarin even got into a legal fight with the FDA when it tried to promote Vascepa for a broader range of patients than the drug had been approved for (the two eventually settled.). In the meantime, Amarin has lost money for years in part because of its decision to plow ahead with REDUCE-IT. It spent about $35 million on the trial in 2017 alone, according to an SEC filing.
Today’s results, however, might change things. “We look forward to presenting the results to the medical community so that they can assess the importance of this trial in regards to clinical practice,” Ballantyne says.
Amarin will hold a conference call this morning to discuss the results.