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Amarin files fish oil-based heart drug Vascepa in Europe

FDA verdict is also due for expanded use of the drug

Vascepa pill

The European Medicines Agency (EMA) has started a review of Irish drugmaker Amarin’s fish oil-derived drug – sold as Vascepa in the US – setting up an approval next year.

The EU filing comes as Vascepa (icosapent ethyl) is also under review by the FDA for a new label claim that the drug can reduce the incidence of heart attack and strokes in high-risk patients, based on the REDUCE-IT trial.

Vascepa is already approved in the US for the treatment of elevated triglycerides – a risk factor for developing heart disease – but it is thought that adding the new cardioprotection wording to the label could dramatically increase its use and turn it into a blockbuster brand.

An FDA verdict on that is due by 28 December, and approval is widely expected after a unanimous recommendation at an advisory committee meeting last month.

The REDUCE-IT data is at the heart of Amarin’s application for icosapent ethyl in the EU, which is seeking approval of the drug to reduce the risk of cardiovascular events in high-risk patients who have their cholesterol levels controlled with statin treatment, but have elevated triglycerides as well as other cardiovascular risk factors.

Amarin says a recent survey of around 7,800 European patients with coronary heart disease and controlled LDL-cholesterol levels found that about 25% of them also had elevated triglycerides levels.

If approved, icosapent ethyl would become the “first and only EMA-approved, non-LDL lowering agent with a cardiovascular disease risk reduction indication as an adjunct to statin therapy in dyslipidaemic patients in Europe,” according to Amarin’s chief executive John Thero.

The company – which has most of its operations in the US – hasn’t revealed yet what’s rollout plans for the drug would be in Europe if approved, such as whether it will self-market the drug or seek a commercial partner.

Sales of Vascepa are buoyant even ahead of the latest US and EU filings, doubling in the third quarter of this year to $112m compared to the same period of 2018, as Amarin starts to expand its salesforce for the drug from 400 to 800 representatives.

REDUCE-IT showed that Vascepa achieved a reduction of 25% in major adverse cardiovascular events (MACE) and a 20% reduction in deaths in high-risk patients.

Other drugs including Amgen's injectable PCSK9 inhibitor Repatha (evolocumab) have achieved a similar level of efficacy in testing but Vascepa’s oral dosing, relatively low cost and absence of side effects is expected to make it particularly attractive to healthcare systems.

Speaking ahead of the FDA advisory committee meeting, Thero said that – based on the REDUCE-IT data – if all statin-treated patients in the US with elevated triglyceride levels were treated with Vascepa “major adverse cardiovascular events such as stroke, heart attack and cardiovascular death could in aggregate be reduced by 150,000 to 450,000 per year.”

Article by
Phil Taylor

3rd December 2019

From: Regulatory

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