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22/07/15
01:11
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Originally posted by railroadman
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Announced this am. RRM
European regulator approves Amgen's anti-cholesterol drug Repatha
Reuters
20 minutes ago
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July 21 (Reuters) - Amgen Inc said the European commission approved its keenly anticipated cholesterol fighting drug, Repatha.
The approval covers patients with a genetic predisposition to high cholesterol, those on maximum doses of statins and those who cannot realize enough benefit from them, the biotechnology company said on Tuesday.
The drug is part of a new class of LDL-lowering drugs that inhibit a protein known as PCSK9. LDL is also called bad cholesterol.
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Seems much broader than what the FDA advisory panel recommended. Will be interesting to see if the US regulators let Europe prove the concept before expanding or follow suit.