Please login to the form below

Not currently logged in
Email:
Password:

FDA approves AZ’s fish oil drug

Epanova gets green light to reduce high levels of fat in the blood
AstraZeneca AZ headquarters London UK

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.

Article by
Thomas Meek

6th May 2014

From: Sales

Share

Tags

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Fishawack Health

Fishawack Health is the leading global commercialization partner for the modern life science era. Established in 2001 and headquartered in...

Latest intelligence

Top 10 benefits of virtual advisory boards
Why virtual advisory boards should be part of every brand's toolbox in the post-COVID new normal....
The Patient Will See You Now – The Evolution of the Doctor-Patient Relationship
The doctor-patient relationship is an ever changing one that changes as society changes. Technology then helps to drive this change along with a wide number of other factors....
Mind the Gap – Challenging Immunisation Apathy and Misinformation
world, the biggest challenges remain apathy and misinformation. Since a measles vaccine was introduced in the UK in 1968, Public Health England estimates that 20 million measles cases and 4,500...