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Amgen's Kyprolis Under EU Review - Analyst Blog

Amgen Inc'sAMGN marketing authorization application for its multiple myeloma drug, Kyprolis, has been accepted for review in the EU. The company is looking to get Kyprolis approved for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy.

Kyprolis enjoys orphan drug status in the EU and was granted accelerated assessment. According to the company press release, multiple myeloma affects approximately 89,000 people in Europe.

Kyprolis, which became a part of Amgen's portfolio following its Oct 2013 acquisition of Onyx, delivered sales of $331 million in 2014.

Kyprolis gained accelerated approval in the U.S. for the treatment of multiple myeloma patients who have received at least two prior therapies including Velcade (bortezomib) and an immunomodulatory agent (IMiD), and whose disease has progressed on or within 60 days of completion of the last therapy.

The company recently submitted a supplemental new drug application (sNDA) for Kyprolis to the FDA to support the conversion of accelerated approval to full approval and expand its label as well.

Meanwhile, Amgen has several pipeline and regulatory events lined up this year. Pipeline candidates like Repatha (dyslipidemia) and Corlanor (chronic heart failure) are currently under regulatory review. The company also plans to submit marketing applications for its moderate-to-severe plaque psoriasis candidate brodalumab in 2015. The company's metastatic melanoma candidate talimogene laherparepvec is also set to be reviewed by an FDA advisory panel on Apr 29.

Amgen currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Cambrex Corp. CBM , ANI Pharmaceuticals ANIP and Cytokinetics Inc. CYTK . All three companies hold a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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