FDA approves AZ’s fish oil drug

AstraZeneca's pipeline continues to bear fruit as it receives its fourth approval of the year from the US FDA for its blood fat lowering drug Epanova.

The approval for Epanova – a mixture of polyunsaturated free fatty acids derived from fish oils – is welcome news for AZ, which is currently battling against a takeover by US rival Pfizer.

Epanova is one of several pipeline-boosting drugs acquired by AZ over the past couple of years since Pascal Soriot took over as CEO. It was originally developed by Omthera Pharmaceuticals – a biotech AZ purchased for $443m in 2013.

The FDA approval covers its use as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridaemia.

The condition is characterised by high levels of triglyceride fat in the blood and can lead to serious health problems, such as diabetes. According to AZ, nearly four million adults in the US currently have severe hypertriglyceridaemia

Epanova is developed to lower levels of triglyceride and has demonstrated its effectiveness in the phase III trials EVOLVE and ESPRIT, both of which formed the basis for the FDA review.

Once launched Epanova will enter a competitive for market for hypertriglyceridemia medicines, including BASF/Pronova's Omacor/Lovaza, another omega-3 fatty acid product.

Omacor/Lovaza achieved end-user sales of around $1.4bn in 2011 and is sold by Abbott Laboratories in the US and various companies including GlaxoSmithKline, Grupo Ferrer and Pierre Fabre in Europe.

The drug is at the end of its patent though and is set to face competition from the Teva's generic version, pushing prices down.

Epanova does offer an advantage over its rival, however, as it does not need to be taken with meals, and has a simpler dosing profile. Its approval follows positive FDA decisions for AstraZeneca's Farxiga (dapagliflozin), Myalept (metreleptin) and a pen injector version of its once-weekly diabetes drug Bydureon.