Amgen has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the marketing authorization of Repatha (evolocumab) recommending approval for use in certain patients with high cholesterol. Repatha is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver’s ability to remove low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, from the blood.

The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). If approved, a centralized marketing authorization with unified labeling will be granted in the 28 countries that are members of the EU. Norway, Iceland, and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions on the basis of the decision of the EC.

The CHMP recommended granting Repatha marketing authorization for: (1)the treatment of adults with primary hypercholesterolemia (heterozygous familial and non-familial [HeFH]) or mixed dyslipidemia, as an adjunct to diet: (2) in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or (3) alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated, and for (4) the treatment of adults and adolescents aged 12 years and over with homozygous familial hypercholesterolemia (HoFH) in combination with other lipid-lowering therapies.

In May 2015, the Endocrinologic and Metabolic Drugs Advisory Committee Committee (EMDAC) of the US Food and Drug Administration (FDA) said it will review data supporting the company’s biologics license application (BLA) for Repatha (evolocumab) for the treatment of high cholesterol at a meeting on June 10, 2015. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of Aug. 27, 2015, for the Repatha BLA.

In seeking approval of evolocumab, Amgen is competing against two other late-stage PCSK9 inhibitors respectively from Sanofi and Pfizer. Sanofi has submitted regulatory filings in the US and EU for Praluent (alirocumab), an investigational monoclonal antibody targeting PCSK9, for which Sanofi is partnered with Regeneron Pharmaceuticals. In January 2015, the FDA accepted for priority review the BLA for the drug with a target action date of July 24, 2015. Also, the EMA accepted for review the marketing authorization application for Praluent in the European Union. Pfizer currently is studying bococizumab, an investigational PCSK9 inhibitor, in a Phase III clinical trial program for its potential to lower LDL-C and improve cardiovascular outcomes.

Source: Amgen