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Amgen says the approval makes Repatha the first PCSK9 inhibitor to be approved in the world.
The European Commission (EC) granted marketing authorization to Amgen’s proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor Repatha (evolocumab) on July 21, 2015 for the treatment of hypercholesterolemia (heterozygous familial and non-familial [HeFH]) or mixed dyslipidemia. The drug is the first in its class to be approved anywhere in the world, beating out market rival Praluent (alirocumab) from Sanofi and Regeneron. According to Reuters, the EC may review Praluent as early as this week.
Although the drug received a broad label, meaning the use of the drug "alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated" was approved, the release also stated that before starting treatment with Repatha, "secondary causes (non-genetic) of excess cholesterol and abnormal fat levels in blood should be excluded." The broad approval for this PCSK9 inhibitor may indicate that this class of drug may eventually reach blockbuster status, as many analysts have predicted.
During an FDA advisory panel ruling on Repatha in June 2015, some physician panelists were concerned that the broad indication for the drug-or its ability to lower low-density lipoprotein (LDL) levels alone-was not supported by long enough trials to adequately assess the safety of the medication. The target action date for the drug in the US is August 27, 2015.