6th May 2014 06:51
LONDON (Alliance News) - AstraZeneca PLC, which has rejected a GBP63 billion takeover offer from US rival Pfizer Inc, Tuesday said the US Food and Drug Administration had approved its Epanova drug as a treatment for reducing high levels of blood fat.
In a statement, the company said the FDA had approved the omega-3-carboxylic acids treatment as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridaemia.
Triglycerides are a type of lipid found in blood, and an essential energy source for the body. However, some people have very high triglyceride levels, known as severe hypertriglyceridaemia, meaning they have too much fat in their blood which can lead to serious health complications.
AstraZeneca didn't say anything more about the Pfizer approach in its statement, after it Friday rejected the US company's latest informal GBP50-a-share. However, it had been expected to release good news about its drugs pipeline as it tries to persuade shareholders that it would be better off continuing as a standalone company.
Most of the world's big pharmaceuticals companies have experienced a problem in recent years because many of the best-selling drugs came off patent, meaning revenues slid as generic treatments arrived on the market. AstraZeneca was perhaps worst hit by this phenomenon.
The drug news comes after AstraZeneca Chairman Leif Johansson urged British Prime Minister David Cameron not to give ammunition to Pfizer?s takeover approach, according to the Financial Times. Johansson cautioned the UK prime minister that the government?s active engagement with Pfizer could allow the US group to claim that Downing Street was in favour of the deal, The FT said, citing one official close to the discussions between the company and Number 10 on Friday.
In its statement Tuesday, AstraZeneca it was planning to evaluate Epanova in other uses.
It will evaluate the safety and efficacy of the drug on cardiovascular outcomes in combination with statin therapy in patients with mixed dyslipidaemia who are at increased risk of cardiovascular disease, it said.
It also plans to pursue the development of a fixed dose combination of Epanova with a statin, and plans to file for regulatory approval in other markets for the severe hypertriglyceridaemia indication.
By Steve McGrath; [email protected]; @SteveMcGrath1
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