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FDA to review Amgen’s cholesterol drug

US regulator accepts first in new class of PCSK9 inhibitors
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Amgen's investigational treatment for high cholesterol evolocumab has been accepted for review by the US FDA.

The regulator will now assess the Biologics License Application (BLA) submitted by Amgen for the monoclonal antibody, which is now on its way to be the first in a new class of medicines called PCSK9 inhibitors to reach market.

The news puts Amgen a step ahead of its rivals in what looks to be a competitive market for new cholesterol-lowering treatments as companies look to a new generation of drugs to offer an alternative to statins such as Lipitor (atorvastatin) and Crestor (rosuvastatin).

Pfizer – the developer of Lipitor – and Sanofi/Regeneron are both competing with Amgen in the PCSK9 field for hyperlipidaemia treatment.

Pfizer's bococizumab (RN316) and Sanofi/Regeneron's alirocumab (REGN727) have both reported positive results in phase III trials and the latter is expected to be filed for approval before the end of the year.

The fight has spilled out into the US courts with Amgen last month launching a lawsuit against Sanofi and Regeneron for patent infringement.

The drugs work by inhibiting the PCSK9 protein that reduces the liver's ability to remove low-density lipoprotein cholesterol – so-called 'bad' cholesterol – from the blood.

In Amgen's case the safety and effectiveness of evolocumab has been investigated in 10 phase III trials, which have been submitted to the FDA in support of the application.

Dr Sean Harper, Amgen's head of R&D, said: "Evolocumab has the potential to provide significant additional benefit when added to existing LDL cholesterol-lowering medications for patients with high cholesterol."

The FDA has set an action date of August 27 for a decision on the use of evolocumab in the US. Amgen has also submitted the drug for use in Europe.

Article by
Thomas Meek

11th November 2014

From: Sales, Regulatory



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