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Amgen Submits Regulatory Application for PCSK9 Inhibitor

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Amgen Inc. (AMGN - Free Report) submitted a Biologics License Application (BLA) seeking FDA approval for its PCSK9 inhibitor, evolocumab (AMG 145) for the treatment of high cholesterol.

Evolocumab works by inhibiting PCSK9, a protein that lowers the liver's ability to remove “bad" cholesterol from the blood.

The BLA was based on results from 10 phase III studies. Amgen has been consistently presenting positive data on evolocumab.

Along with filing the BLA, Amgen reported positive top-line results on evolocumab from the phase III YUKAWA-2 study (StudY of LDL-Cholesterol Reduction Using a Monoclonal PCSK9 Antibody in Japanese Patients With Advanced Cardiovascular Risk). The study, which was conducted in Japanese patients with high cardiovascular risk and high cholesterol, met its co-primary endpoints.

We are pleased with Amgen’s progress with its pipeline. The company recently received priority review status for ivabradine for the treatment of chronic heart failure. Meanwhile, evolocumab is one of the most promising pipeline candidates in the company’s pipeline. We believe evolocumab has huge market potential.

However, although Amgen’s regulatory application may be the first BLA to be submitted for a PCSK9 inhibitor, the race to bring the first PCSK9 inhibitor to market is heating up. Sanofi (SNY - Free Report) and Regeneron (REGN - Free Report) are collaborating on the development of a PCSK9 inhibitor, alirocumab. The companies intend to use an FDA rare pediatric disease priority review voucher for the BLA submission for alirocumab. Sanofi and Regeneron are not far behind Amgen and expect to file for regulatory approval in the U.S. by year end.

Amgen is a Zacks Rank #1 (Strong Buy) stock. An equally well-ranked stock is Cambrex Corp. (CBM - Free Report) .

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