The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended Amarin’s fish oil-derived drug icosapent ethyl for the prevention of cardiovascular events in high-risk patients.
The CHMP has adopted a positive opinion for marketing authorisation of the drug under the brand name Vazkepa in the EU.
The committee has recommended use of the drug in adult patients already receiving statin treatment, and who have elevated triglycerides.
Patients must also have established cardiovascular disease or diabetes and at least one other cardiovascular risk factor.
In December 2019, the US Food and Drug Administration (FDA) approved the drug with the brand name Vascepa, also to reduce the risk of cardiovascular events in high-risk patients.
At that time, Vascepa became the first FDA-approved drug to reduce cardiovascular risk among patients with elevated triglyceride levels as an add-on to maximally tolerated statin therapy.
Similar to the FDA approval, the CHMP recommendation is supported by results from the REDUCE-IT trial, which evaluated Amarin’s drug in over 8,000 statin-treated adults with elevated cardiovascular risk.
In this trial, it achieved a reduction of 25% in major adverse cardiovascular events (MACE) and a 20% reduction in deaths.
Following the CHMP recommendation, the European Commission will now review the application, with a decision expected within 67 days of the positive opinion.
“This positive CHMP opinion is a significant milestone for Amarin, taking us one step closer to making this important therapy available to millions of patients in the European Union at high risk of cardiovascular events such as heart attacks and strokes,” said Steven Ketchum, senior vice president, president of R&D and chief scientific officer of Amarin.
“We are dedicated to supporting a rethinking of cardiovascular disease risk reduction in Europe with further emphasis on preventative care,” he added.
Approval in the EU will be particularly important for Amarin, after the company was hit with a judgment ruling that invalidates key patents taking the drug in the US.
In March 2020, a Nevada district court judge ruled that six patents on Vascepa (icosapent ethyl) – which were set to expire in 2030 – are invalid.
Amarin was hit again in September 2020, after the US Court of Appeals upheld the lower court’s ruling that invalidated the patents covering Vascepa.
In a statement, Amarin said that it would be ‘reviewing its legal options’ following the US Court of Appeal’s ruling.
“We are […] excited about the anticipated commercialisation opportunities for Vascepa in Europe as we prepare for expected approval and launch in early 2021,” said John Thero, president and chief executive officer of Amarin
“At the same time, we will continue to meet the strong demand for Vascepa […] in the US through our proven manufacturing capabilities,” he added.