Ivabradine

Human medicines European public assessment report (EPAR): Ivabradine Anpharm, ivabradine, Date of authorisation: 08/09/2015, Revision: 10, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Ivabradine Anpharm, ivabradine, Date of authorisation: 08/09/2015, Revision: 10, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Ivabradine Anpharm, ivabradine, Date of authorisation: 08/09/2015, Revision: 10, Status: Authorised

REGENCOR EXPANDS SCIENTIFIC ADVISORY BOARD

Retrieved on: 
Wednesday, March 22, 2023

to its Scientific Advisory Board.

Key Points: 
  • to its Scientific Advisory Board.
  • He has worked with the FDA and is a consultant for the Endocrinologic and Metabolic Drugs Advisory Committee.
  • "Regencor is uniquely positioned to advance treatments for myocardial infarction and to help prevent the progression to heart failure."
  • "We are delighted and honored to have such accomplished scientific leaders join our Scientific Advisory Board," said Sean Edwards, Chief Executive Officer of Regencor.

Olatec Therapeutics LLC Announces a Scientific Publication on the Positive Results in the First Known Clinical Trial with a Selective Oral NLRP3 Inhibitor, Dapansutrile, in Patients with Heart Failure

Retrieved on: 
Thursday, February 11, 2021

Olatec Therapeutics LLC (Olatec) today announced the publication of the clinical data on its Phase 1b clinical study of patients with heart failure with reduced ejection fraction (HFrEF).

Key Points: 
  • Olatec Therapeutics LLC (Olatec) today announced the publication of the clinical data on its Phase 1b clinical study of patients with heart failure with reduced ejection fraction (HFrEF).
  • There were no deaths or Significant Adverse Events, and any Adverse Events were mild and self-limiting.
  • Several indicators suggesting a potential positive effect of dapansutrile were observed in cohort 3, the high dose group of patients.
  • It has been reported that heart failure affects around 26 million people worldwide and is increasing in prevalence.

Results From SOLOIST and SCORED Outcomes Studies Presented at Late-Breaking Science Session of American Heart Association Scientific Sessions and Published in The New England Journal of Medicine

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Tuesday, November 17, 2020

The key results from SOLOIST and SCORED were presented today at the Late-Breaking Science Session of the American Heart Association (AHA) Scientific Sessions 2020 and simultaneously published in The New England Journal of Medicine (NEJM) in two separate articles titled: Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure and Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease.

Key Points: 
  • The key results from SOLOIST and SCORED were presented today at the Late-Breaking Science Session of the American Heart Association (AHA) Scientific Sessions 2020 and simultaneously published in The New England Journal of Medicine (NEJM) in two separate articles titled: Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure and Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease.
  • SCORED demonstrates that sotagliflozin significantly reduces heart failure events in a patient population with stage 3 and 4 chronic kidney disease and cardiovascular risk.
  • Treatment with sotagliflozin resulted in a significantly lower total number of cardiovascular deaths, heart failure hospitalizations and urgent visits as compared to placebo.
  • Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

Amgen, Cytokinetics and Servier Announce Topline Results From GALACTIC-HF, a Phase 3 Trial of Omecamtiv Mecarbil in Patients With Heart Failure

Retrieved on: 
Thursday, October 8, 2020

We are pleased to have collaborated with Amgen and Cytokinetics on one of the largest heart failure trials ever conducted to investigate this novel therapy in patients with heart failure.

Key Points: 
  • We are pleased to have collaborated with Amgen and Cytokinetics on one of the largest heart failure trials ever conducted to investigate this novel therapy in patients with heart failure.
  • The primary composite endpoint of this double-blind, placebo-controlled, event-driven trial was time to CV death or first heart failure event (heart failure hospitalization and other urgent treatment for heart failure).
  • Omecamtiv mecarbil is being developed by Amgen in collaboration with Cytokinetics, with funding and strategic support from Servier.
  • Omecamtiv mecarbil is the subject of an international clinical trials program in patients with heart failure including GALACTIC-HF and METEORIC-HF.

Investigational Drug Vericiguat Significantly Reduced the Risk of the Composite Endpoint of Heart Failure Hospitalization or Cardiovascular Death, Compared to Placebo, When Given in Combination with Available Heart Failure Therapies

Retrieved on: 
Saturday, March 28, 2020

Patients enrolled in VICTORIA were at high risk of hospitalization and cardiovascular death following a recent heart failure decompensation.

Key Points: 
  • Patients enrolled in VICTORIA were at high risk of hospitalization and cardiovascular death following a recent heart failure decompensation.
  • Vericiguat, when given in combination with available heart failure therapies, met the primary efficacy endpoint of reducing the risk for the composite endpoint of heart failure hospitalization or cardiovascular death in patients with worsening chronic heart failure with reduced ejection fraction (HFrEF), compared to placebo.
  • In the VICTORIA trial, vericiguat met its primary endpoint, achieving a significant reduction in the risk of cardiovascular death and hospitalization for heart failure in these patients overall when given in combination with available heart failure therapies.
  • The primary endpoint of the study is the composite of time to first occurrence of heart failure hospitalization or cardiovascular death.

New Results From COSMIC-HF Presented at AHA 2019 Show Treatment of Heart Failure Patients With Omecamtiv Mecarbil Was Associated With Neutral or Improved Measures of Diastolic Function

Retrieved on: 
Monday, November 18, 2019

Specifically, in patients receiving omecamtiv mecarbil E-wave velocity, E/A-ratio, and E/e or e were not significantly changed compared to placebo.

Key Points: 
  • Specifically, in patients receiving omecamtiv mecarbil E-wave velocity, E/A-ratio, and E/e or e were not significantly changed compared to placebo.
  • It is designed to evaluate whether treatment with omecamtiv mecarbil, when added to standard of care, reduces the risk of heart failure events (heart failure hospitalization and other urgent treatment for heart failure) and CV death in patients with HFrEF.
  • Adverse events (AEs), including serious AEs, in patients on omecamtiv mecarbil were comparable to placebo.
  • Omecamtiv mecarbil is the subject of an international clinical trials program in patients with heart failure including GALACTIC-HF and METEORIC-HF.

Merck and Bayer’s Investigational Drug Vericiguat Meets Primary Endpoint in Phase 3 Study of Patients with Worsening Chronic Heart Failure

Retrieved on: 
Monday, November 18, 2019

Vericiguat reduced the risk of the composite endpoint of heart failure hospitalization or cardiovascular death in patients with worsening chronic heart failure with reduced ejection fraction (HFrEF) compared to placebo when given in combination with available heart failure therapies.

Key Points: 
  • Vericiguat reduced the risk of the composite endpoint of heart failure hospitalization or cardiovascular death in patients with worsening chronic heart failure with reduced ejection fraction (HFrEF) compared to placebo when given in combination with available heart failure therapies.
  • VICTORIA is the first large contemporary outcomes study to focus exclusively on a population with worsening chronic heart failure who have a high risk for cardiovascular mortality and repeated heart failure hospitalizations.
  • We are pleased with the positive outcome with vericiguat as the first sGC stimulator evaluated in patients with worsening chronic heart failure with reduced ejection fraction.
  • The primary endpoint of the study is the composite of time to first occurrence of cardiovascular death or heart failure hospitalization.