Omthera Pharmaceuticals developed fish oil drug Epanova. (Photo Credit: Omthera Pharmaceuticals/FIS)
Fish oil drug for heart disease could be approved by FDA
Friday, September 20, 2013, 04:50 (GMT + 9)
The US Food and Drug Administration (FDA) is to review a new experimental drug containing fish oil and will take a final decision on its approval by early May next year.
The product, called Epanova, has been designed for treating people with very high levels of fatty triglycerides in their blood. It was developed by Omthera Pharmaceuticals, which AstraZeneca (AZ) acquired earlier this year, Reuters reported.
When AZ bought Omthera Pharmaceuticals for USD 443 million, the firm also gained the rights for the fish oil drug. At that time, Epanova was deemed as the company’s best product.
This fish oil drug is composed of a mixture of polyunsaturated free fatty acids derived from fish oils, including omega-3 and omega-6 fatty acids and is taken in the form of a soft gelatin capsule.
In July this year, Omthera filed for US approval after it was proved that the drug was able to lower very high triglycerides and reduce non-HDL cholesterol when used in combination with a statin for patients with high triglycerides.
Hypertriglyceridaemia can be caused by several factors including excessive alcohol intake, high fat diet, genetic predisposition for people with familial hypertriglyceridemia, as well as certain medical conditions and medications.
AZ is also collaborating with Moderna Therapeutics, Oxford Cancer Biomarkers and the Karolinska Institutet.
AZ has also acquired cancer specialist Amplimmuneand US biotech AlphaCore Pharma, a USD 1.15 billion deal to buy respiratory specialist Pearl Therapeutics and the purchase of a drug developed by FibroGen for anaemia associated with chronic kidney disease.
By Gabriela Raffaele