Shares in Irish company Amarin Corp nosedived yesterday after a US Food and Drug Administration (FDA) advisory committee voted against approval of its fish oil-based therapy in a broader patient population.
By a 9-2 margin, the panel said it would not support approval of the omega-3 fatty acid based Vascepa (icosapent ethyl) as a combination therapy with statin drugs for people with elevated triglycerides (between 200 and 499mg/dL) until it is able to review data from an ongoing outcomes study called REDUCE-IT.
Amarin was hoping to win approval for Vascepa on the strength of data from the ANCHOR trial showing that taking the drug reduced elevated serum triglycerides, a risk factor for cardiovascular disease.
The negative votes seem to stem mainly from a wish to see hard endpoints and the view that while Vascepa’s effects on triglycerides are clear, its effects on other lipids in the blood, such as low- and high-density lipoprotein-cholesterol (LDL-C and HDL-C) are less so.
Moreover, the FDA reviewer said in documents filed ahead of the meeting that recent trials in multiple drug classes “have failed to demonstrate a reduction in cardiovascular risk” when other lipid-altering treatment are added to statins.
One of the claims made by Amarin for Vascepa is that it reduces triglycerides without raising LDL-C, which could differentiate it from Lovaza/Omacor (omega-3-acid ethyl esters), another omega-fatty acid based product sold by GlaxoSmithKline (GSK), as well as other drug classes such as the fibrates.
The drug is already approved to reduce extremely high triglyceride levels (>500mg/dL) in patients not taking statins, but the broader indication is seen as key to its commercial success as such a high proportion of patients with dyslipidaemia take these drugs.
With the REDUCE-IT trial not due to generate results until 2017 (although an interim look at the data is due in 2015), the verdict could mean a lengthy delay for Vascepa and a major setback for the company’s hope to grow its sales, which were a little over $7m in the first five months on the market since its US launch in January 2013.
Lovaza sales in the first half of this year were around $500m and ahead of the FDA committee meeting, analysts had suggested Vascepa could reach sales of $1bn or more as an adjunct to statin therapy.
Meanwhile, the cost of running REDUCE-IT is also a drain on Amarin’s finances, with the bill for 2013 expected to come in at somewhere between $30m and $40m. The company was sitting on cash reserves of $150m at the end of June.