MHRA authorises Amarin’s heart drug Vazkepa

Amarin’s Vazkepa has received authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as a treatment to reduce the risk of cardiovascular (CV) events in high-risk patients.

The Great Britain marketing authorisation for Vazkepa (icosapent ethyl) covers the use of the drug to reduce the risk of CV events in high CV risk statin-treated adult patients who have elevated triglycerides and either established CV disease or diabetes and at least one additional CV risk factor.

In the REDUCE-IT trial in 8,179 statin-treated adult patients with moderately elevated triglyceride levels, Vazkepa reduced the risk of major adverse CV events by 25%, with an absolute risk reduction of 4.8%.

The drug also demonstrated a 26% relative risk reduction and a 3.6% absolute risk reduction in the key secondary composite endpoint of time to first occurrence of cardiovascular death, heart attack or stroke.

“We began developing Vazkepa in Europe more than a decade ago. We are very grateful to the many patients and physicians who contributed to the development and clinical study of Vazkepa,” said John Thero, president and chief executive officer of Amarin.

“We are dedicated to a rethinking of cardiovascular disease risk reduction in Europe with an emphasis on preventative care. We will work tirelessly throughout Europe to make Vazkepa available to all patients who may benefit from this therapy,” he added.

In a statement, Amarin added that, to its understanding, Vazkepa is among the first products to be submitted and licensed through the MHRA’s new ‘reliance’ route following the end of the BREXIT transition period.