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Europe approves Lilly's Plavix rival

Published on 25/02/09 at 10:51am

Lilly and Daiichi Sankyo have won European approval for their blood-thinning drug Efient, which will go up against established blockbuster Plavix.

The European approval is further good news after the drug got the green light from a key FDA committee, meaning the drug looks set for US approval.

Efient had been severely delayed by concerns over uncontrolled bleeding seen in some patients.

But phase III data also suggests Efient is superior to Plavix in reducing the risk of major cardiovascular events, and this benefit/risk balance seems to have persuaded regulators on both sides of the Atlantic.

Lilly had requested that the drug carry a claim of superiority over Plavix in this respect, and the panel members agreed that the FDA could consider this claim.

Regulators gave it a green light to be used to prevent blood clots in patients who have suffered a heart attack and have acute coronary syndrome (ACS) and who are having an operation to widen an artery, called a percutaneous coronary intervention (PCI).

John Lechleiter, chief executive of Lilly, said Efient's approval will help to meet an important medical need.

He said: "Survivors of heart attacks have a substantial risk of suffering from one or more additional heart attacks. This [approval] action is a major step forward in giving healthcare professionals and patients in European countries a new anti-platelet option for treating ACS."

Efient (prasugrel) works by reducing the levels at which blood platelets stick or clumping together, which can result in clogged arteries and can lead to a heart attack or stroke.

The drug has been closely watched in late-stage development, as it will go up against blockbuster Plavix, which is marketed by Bristol-Myers Squibb and Sanofi-Aventis.

Analysts expect Efient to reach blockbuster status, hitting global sales of $1.15 billion in 2013, but it is not expected to match the commercial success Plavix has achieved.

Plavix earned $5.6bn in 2008, but is set to lose its US patent in 2011 and across Europe in 2013.

For Lilly, the launch is particularly important as it hopes Efient can help replace some of the revenue lost when its flagship product Zyprexa goes off patent in the US in 2011.

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