Tag Archives: LDL-C

March, 2017

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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1 November
Pfizer Discontinues Development of its Investigational PCSK9 Inhibitor

Tuesday, November 1, 2016 – 6:30am EDT — Pfizer Inc. announced today the discontinuation of the global clinical development program for bococizumab, its investigational Proprotein Convertase Subtilisin Kexin type 9 inhibitor (PCSK9i). The totality of clinical information now available for bococizumab, taken together with the evolving treatment and market landscape for …
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19 October
The Medicines Company’s PCSK9 Drug Demonstrates Positive Results in Mid-Stage Study

PARSIPPANY, N.J.–(BUSINESS WIRE)–The Medicines Company (NASDAQ:MDCO) today announced top-line results from the interim analysis with Day 90 follow-up for all 501 patients enrolled in the ongoing ORION-1 study of PCSK9si, its investigational first-in-class PCSK9 synthesis inhibitor. Data from the interim analysis confirm the significant and durable LDL-C reduction demonstrated up …
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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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1 April
Pfizer’s PCSK9 Inhibitor Succeeds in its Second Late-Stage Study

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. announced that the Phase 3 SPIRE-AI (AutoInjector) trial of the investigational Proprotein Convertase Subtilisin Kexin type 9 inhibitor (PCSK9i) bococizumab administered with a pre-filled pen met its co-primary endpoints: percent change from baseline in low-density lipoprotein cholesterol (LDL-C) reduction at 12 weeks compared to placebo and …
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