Amgen Completes Enrollment For A Phase 3 Study For Cholesterol Drug

Today Amgen (AMGN) announced that it had started a pivotal phase 3 trial for its cholesterol drug known as evolocumab. The phase 3 trial, known as Fourier,  has recruited up to 27,500 patients to determine if evolocumab provides efficacy for these patients. The trial will compare evolocumab together with statin therapy, against a placebo compound with statin therapy. 

Investors might have to wait awhile for these results because the company doesn't expect any trial readout until 2017. The primary endpoint of this trial is to determine if evolocumab can reduce cardiovascular events in patients with high cholesterol as compared to the placebo compound. This drug compound, evolocumab, will be marketed as Repatha. 

The CHMP (ad panel recommending body for Europe) already recommended Repatha for approval, and now the EMA -- European Commission will have up to 60 days to determine if Repatha should ultimately be approved for marketing. An FDA advisory panel is set to meet on June 10 to discuss Repatha's potential approval, although the FDA won't finally decide upon approval for Repatha until August 27, 2015. 

Amgen's drug evolocumab is a monoclonal antibody drug that inhibits PCSK9, and that is important because PCSK9  is responsible for reducing the body's ability to remove LDL-C -- bad cholesterol -- from the body. Amgen will more than likely face competition from Regeneron (REGN) and Sanofi (SNY), which also both have a cholesterol-lowing drug known as alirocumab -- to be marketed as Praluent. The competition in this market will become even more intriguing than in the past. 

Disclosure: No positions mentioned.

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