Fish oil capsules. (Photo: Stock File/FIS)
FDA approves fish oil supplement for hypertriglyceridemia patients
Monday, July 30, 2012, 04:00 (GMT + 9)
Biopharmaceutical company Amarin Corporation plc has announced that the US Food and Drug Administration (FDA) has approved its VascepaTM (icosapent ethyl) fish oil capsules as a supplement to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.
Vascepa is a purified marine-oil preparation consisting of "not less than 96 per cent" EPA, an omega-3 fatty acid. Amarin submitted the New Drug Application (NDA) for the use of Vascepa in September 2011.
The company spent the last 18 months setting up manufacturing supply lines and discussing partnerships to make and sell the fish oil capsules. Analysts anticipate huge sales and possibly even a buyout offer, Fierce Pharma reports.
"FDA approval of Vascepa represents the introduction of an important new treatment option for patients with severe hypertriglyceridemia,” stated Joseph Zakrzewski, chairperson and CEO of Amarin. “In Amarin's MARINE clinical trial, Vascepa demonstrated a statistically significant placebo-adjusted reduction in levels of triglycerides without elevation in levels of LDL-C, commonly referred to as 'bad cholesterol'."
The commercial launch of Vascepa is expected for early in the first quarter of 2013.
After obtaining positive results from two late-stage studies which helped the company get approval from the FDA, Amarin acquired supply agreements while preparing for an aggressive marketing campaign for the product. The firm inked deals with two manufacturers of active pharmaceutical ingredients and a couple of encapsulators.
Citi Investment Research forecasts the drug could reach sales as high as USD 2.6 billion.
“We continue to consider three potential paths for the marketing and sale of the product: an acquisition of Amarin, a strategic collaboration or self-commercialization, the latter of which could include third-party support. We are now focused on continued commercial preparations for Vascepa which includes, but is not limited to, finalizing the introduction of Vascepa to managed care plans to gain formulary access, building-up inventory levels and coordinating other pre-launch marketing activities," Zakrzewski added.
In a clinical trial, Vascepa lowered triglyceride levels by 33 per cent compared to a placebo in patients with baseline levels greater than 500 mg/dl.
It will become the market's second omega-3 polyunsaturated fatty acid (PUFA) product available only by prescription, The Heart.org reports.
By Natalia Real