Sanofi's big new cholesterol drug wins European green light

[July 24, 2015]  By Ben Hirschler

LONDON (Reuters) - A new type of cholesterol drug from Sanofi and Regeneron Pharmaceuticals won a green light from European regulators on Friday, two months behind a rival product from Amgen.

The European Medicines Agency (EMA) said its experts had recommended Praluent for patients unable to control their cholesterol despite taking optimal doses of conventional statin pills or who cannot take statins.

Praluent and Amgen's Repatha, which are both given as injections, will cost much more than statins but they offer a way to reduce cholesterol levels significantly for patients at high risk of heart problems.

They belong to a drug class known as PCSK9 inhibitors and are expected to generate global annual sales of more than $2 billion each by 2020, according to consensus forecasts compiled by Thomson Reuters Cortellis.

Amgen's Repatha was formally approved by the European Commission on Tuesday after a positive EMA opinion in May and Praluent is likely to be cleared by the Commission after a similar period of around two months.

In the United States, the tables may be turned, since the Food and Drug Administration is due to give its verdict on Praluent by July 24, potentially putting Sanofi and Regeneron's product ahead of Amgen's.

The companies are heading for a major marketing fight, given the two drugs' similar mode of action, although there are significant differences in dosing that will play an important role in determining how they are used.

The competing products target the PCSK9 protein that maintains "bad" LDL cholesterol in the blood. Statins, like Pfizer's Lipitor, work very differently, blocking the liver's production of LDL cholesterol, which is linked with heart attacks and strokes.

(Editing by William Hardy)

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