FDA approves Amarin’s Vascepa for severe hypertriglyceridaemia

The FDA on Thursday approved Amarin’s Vascepa (icosapent) as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridaemia. A decision on whether Vascepa, formerly known as AMR101, will be granted five years of market exclusivity as a new chemical entity has not been announced and will not likely be public until August, Amarin said.

The safety and efficacy of the therapy was based on data from the MARINE trial, which randomised adult patients with fasting triglyceride levels of between 500 mg/dL and 2000 mg/dL to receive Vascepa or placebo. After 12 weeks, patients given the 4-gram dose of Amarin's drug demonstrated a significant placebo-adjusted median triglyceride reduction of 33 percent and did not show an increase in LDL-cholesterol levels relative to placebo.

In addition, the 4-gram dose of the therapy also showed significant placebo-adjusted median reductions from baseline in non-HDL cholesterol of 18 percent, total cholesterol of 16 percent, very-low-density lipoprotein cholesterol of 29 percent, and apolipoprotein B of 9 percent.

Amarin is planning on a commercial launch of Vascepa in the first quarter of 2013, but it remains unclear as to who will commercialise the therapy. Amarin is currently considering three strategies, notably a potential sale of the company, a partnership, or the possibility of marketing the drug on its own.

Jon Lecroy, an analyst with MKM Partners, said Vascepa may have an advantage over GlaxoSmithKline's omega-3 prescription drug Lovaza because it does not raise bad cholesterol levels, a possible side effect of the UK drugmaker's product. Lecroy said Amarin's drug could reach sales of $1.25 billion in 2017, adding that "there will be interest from large pharmaceutical companies…any company with a large cardiovascular or diabetes sales force makes sense."

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