Tag Archives: Repatha

November, 2018

14 November
Amgen Presents Results Highlighting the Long-Term Safety and Efficacy of Repatha in the Longest Duration Study of a PCSK9 Inhibitor to Date

THOUSAND OAKS, Calif., Nov. 12, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced the final report of the Open-Label Study of Long-TERm Evaluation Against LDL-C (OSLER-1), demonstrating long-term treatment with Repatha® (evolocumab) was associated with robust and consistent reductions in low-density lipoprotein cholesterol (LDL-C), with no increase in overall rates of adverse events over time and no neutralizing antibodies. …
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28 July
FDA Grants Priority Review for Amgen’s sBLA for Repatha

THOUSAND OAKS, Calif., July 27, 2017 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review for Amgen’s supplemental Biologics License Application (sBLA) for Repatha® (evolocumab), a PCSK9 inhibitor. If approved by the FDA, the U.S. Prescribing Information for Repatha will …
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15 March
Amgen’s PCSK9 Inhibitor Repatha Meets Primary Endpoint in Late-Stage Clinical Trial

THOUSAND OAKS, Calif., March 14, 2017 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that four-year follow-up results from the Repatha® (evolocumab) OSLER-1 study, the longest PCSK9 inhibitor clinical trial to date, were published in JAMA Cardiology. Repatha, when added to standard of care (SOC), achieved median low-density lipoprotein cholesterol (LDL-C) reductions …
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11 July
FDA Approves Amgen’s Single Monthly Injection for a PCSK9 Inhibitor

THOUSAND OAKS, Calif., July 11, 2016 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the Repatha® (evolocumab) Pushtronex™ system (on-body infusor with prefilled cartridge), a new, monthly single-dose administration option.1 The Pushtronex system is a hands-free device designed to provide 420 …
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11 May
Cigna Signs Value Contracts for New PCSK9 Inhibitor Cholesterol Drugs

BLOOMFIELD, Conn., 11 May, 2016 – Cigna (NYSE: CI) has entered into new value-based contracts with both Amgen and Sanofi/Regeneron for their PCSK9 inhibitors for commercial business. The contracts modify the cost of the new cholesterol-lowering drugs Repatha TM and Praluent ® based on how well customers respond to the medications, …
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28 August
FDA Approves Amgen’s PCSK9 Inhibitor Repatha

The U.S. Food and Drug Administration today approved Repatha (evolocumab) injection for some patients who are unable to get their low-density lipoprotein (LDL) cholesterol under control with current treatment options. Repatha, the second drug approved in a new class of drugs known as PCSK9 inhibitors, is approved for use in addition to …
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