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FDA to review AZ's fish oil drug Epanova

Hypertriglyceridaemia treatment acquired as part of Omthera takeover
AstraZeneca AZ headquarters London UK

AstraZeneca (AZ) is starting to see the fruits of its series of pipeline-boosting acquisitions in the past year with US regulators accepting for review the company's investigational drug Epanova.

The US Food and Drug Administration (FDA) will assess Epanova for use in the treatment of patients with severe hypertriglyceridaemia – an excess of fatty molecules called triglycerides in the blood. Review is expected to be completed by May 2014.

AZ gained rights to the drug earlier this year following its acquisition of Omthera Pharmaceuticals in deal worth up to $443m.

At the time, Epanova was noted as the company's lead product candidate, and Omthera later filed for US approval in July 2013 based on two phase III trials which demonstrated 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.

The drug taken as a soft gelatin capsule, and contains a mixture of polyunsaturated free fatty acids derived from fish oils, including omega-3 and omega-6 fatty acids.

By tackling triglycerides, these oils can have benefits for patients with severe hypertriglyceridaemia, which can lead to coronary artery disease, skin disorders, pancreatitis and enlargement of the liver.

The disease can be caused by several factors, including high fat diet, excessive alcohol intake, certain medications and medical conditions, as well as a genetic predisposition for people with familial hypertriglyceridemia.

The FDA's decision to accept the New Drug Application (NDA) for Epanova is an early sign that AZ's decision to improve its flagging pipeline through a succession of acquisitions and collaborations may pay off.

These other deals include the acquisition of cancer specialist Amplimmune and US biotech AlphaCore Pharma; the acquisition of a drug developed by FibroGen for anaemia associated with chronic kidney disease; and a $1.15bn deal to purchase respiratory specialist Pearl Therapeutics.

AZ has also entered research collaborations with Moderna Therapeutics, the Karolinska Institutet and Oxford Cancer Biomarkers.

Article by
Thomas Meek

19th September 2013

From: Sales

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