Amarin’s Vascepa gets priority review for cardiovascular label expansion

Amarin’s cardio drug Vascepa (icosapent ethyl) has been granted Priority Review designation by the FDA after trial results showed it could reduce the risk of major cardio events by up to 25%.

These strong results have led some investors to predict blockbuster sales for the drug after the label expansion, as well as a takeover for Amarin.

If approved, Vascepa – a therapeutic strength version of fish oil – will be the first drug indicated to reduce residual cardiovascular risk in patients with statin-managed LDL-C cholesterol, but persistent elevated triglycerides, an important indicator of cardiovascular disease.

The drug is currently indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia, an important but much smaller patient population than can be addressed with an approval of the new application.

There is still the potential that the FDA will hold an Advisory Committee panel review for the application, with Amarin calling the prospect ‘likely’ as this could be the first drug approved for this particular patient population.

The application was based on results from the REDUCE-IT trial, which investigated Vascepa in patients with high cardiovascular risk who, despite stable statin therapy, had elevated triglyceride levels (at least 135 mg/dL).

The drug achieved the primary endpoint with a 25% relative risk reduction compared to placebo in the first occurrence of a major adverse cardiovascular event (MACE) in the intent-to-treat population.

In REDUCE-IT, MACE consisted of a composite of cardiovascular death, nonfatal myocardial infarction (MI or heart attack), nonfatal stroke, coronary revascularisation (procedures such as stents and by-pass) and unstable angina requiring hospitalisation.

Vascepa also achieved seven other secondary endpoints, including a 20% relative risk reduction in cardiovascular death compared to placebo.

Adverse events occurring at greater than 5% and greater than placebo were: peripheral edema (6.5% Vascepa versus 5.0%), although there was no increase in the rate of heart failure in Vascepa patients; constipation (5.4% Vascepa versus 3.6%), although mineral oil, as used as placebo, is known to lower constipation; and atrial fibrillation (5.3% Vascepa versus 3.9%), although there were reductions in rates of cardiac arrest, sudden death and myocardial infarctions observed in Vascepa patients.