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UK’s NICE grants access to Amarin’s cholesterol drug amid US staff cuts – Endpoints News

Britain’s National Institute for Health and Care Excellence, or NICE, agreed on Friday to cover Amarin’s controversial cholesterol drug, Vaskepa, amid turmoil for Amarin.

Amarin and NICE have agreed a price of £144.21 for 120 softgels (or $181 for a 30-day supply), according to Amarin. Low-cost generic versions of Vascepa, known as icosapent ethyl, cost around $100 in the United States, according to GoodRx.

NICE said Vascepa may benefit around 425,000 people in the UK and Wales through its ability to reduce the risk of heart attacks and strokes in people with low-density lipoprotein cholesterol controlled or LDL-C otherwise known as “bad” cholesterol, who are taking a statin and who have high levels of triglycerides.

“Icosapent ethyl is the first approved treatment of its kind for people at risk of heart attacks and strokes despite well-controlled LDL cholesterol because they have increased blood fats. And while lifestyle changes, including diet and exercise, can help reduce their risk, they may not work for everyone,” said Helen Knight, acting director of assessment. medicines to NICE, in a press release.

For people with high triglycerides whose LDL-C levels are controlled by statins and who have cardiovascular disease, Vascepa or icosapent ethyl can reduce their risk of cardiovascular events by more than a quarter, according to NICE. Amarin’s Vascepa, an omega-3 fatty acid derived from fish oil composed only of EPA, was initially approved by the US regulator as a treatment for high triglycerides.

Final NICE guidelines are expected to be published on July 13, after which all local NHS formularies should make the product available within 3 months, according to Amarin.

“This positive recommendation is the result of several months of constructive scientific discussions with multiple stakeholders and a detailed systematic review of clinical and economic evidence,” Laurent Abuaf, SVP and President of Amarin Europe, said in a statement. “After Sweden, this is now the second health technology assessment in Europe that recognizes the potential value of VAZKEPA to strengthen cardiovascular care in England and Wales.”

However, this good news from NICE comes on the heels of some big shakeups.

On Monday, the drugmaker announced that it would cut 65% of its sales staff in the United States, which will effectively lead to a 90% drop from pre-pandemic levels and a 40% reduction in the total number. of employees. Amarin’s chief financial officer, Michael Kalb, also announced his resignation.

Last year, the Supreme Court rejected Amarin’s latest attempt to reclaim its heart drug patents.

The first generic version of Vascepa was approved in the United States in 2020.

News of the NICE recommendation also didn’t help make investors more bullish, as $AMRN stock price was flat today and is still down more than 49% since the start of the month. the year.