Tag Archives: PCSK9

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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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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31 August
The Medicines Company Provides Update on Dyslipidemia Programs

PARSIPPANY, N.J.–(BUSINESS WIRE)–The Medicines Company (NASDAQ:MDCO) today provided an update on its clinical dyslipidemia research programs for MDCO-216 (which contains APoA-1 Milano) and PCSK9si (PCSK9 synthesis inhibitor). MDCO-216. A planned, interim analysis of the first 40 randomized patients completing treatment in the MILANO-PILOT study of MDCO-216 has been reviewed by …
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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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31 July
FDA Approves Sanofi’s PCSK9 Drug Praluent

PARIS and TARRYTOWN, N.Y., July 24, 2015 /PRNewswire/ — Sanofi and Regeneron Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Praluent® (alirocumab) Injection, the first FDA-approved treatment in a new class of drugs known as PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors. Praluent is indicated as …
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10 March
Specialty Therapies Drive Significant Increase in US Drug Spending in 2014

Spending on specialty drugs took a record rise in the US in 2014, largely due to new expensive, yet effective, hepatitis C drugs, according to new data released today in the 2014 Express Scripts Drug Trend Report. According to the pharmacy benefit manager’s (PBM) report, new hepatitis C drugs’ high …
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