News | September 29, 2009

Multaq (dronedarone) Recommended for European Approval

September 28, 2009 – Sanofi-aventis announced last week the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a positive opinion recommending to grant a marketing authorization in the European Union for Multaq (dronedarone 400mg tablets).

The CHMP has recommended the approval of Multaq in adult clinically stable patients with history of, or current nonpermanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate.

In the Summary of Positive Opinion, the CHMP has acknowledged that dronedarone has been shown, in addition to its rhythm and rate controlling properties, to decrease the risk of atrial fibrillation-related hospitalizations.

The positive opinion from the CHMP needs now to be ratified by the European Commission. The opinion is based on the submission of a comprehensive clinical data package including seven international, multicenter, randomized clinical trials involving more than 7,000 patients and including the landmark ATHENA trial.

The ATHENA trial involved 4,628 patients with atrial fibrillation/atrial futter or a recent history of these conditions and showed that Multaq (dronedarone) in addition to standard therapy, reduced the combined endpoint of cardiovascular hospitalization or death from any cause by 24 percent when compared to placebo, meeting the study’s primary endpoint. Reported significant adverse events in the Multaq arm included diarrhea, nausea, bradycardia, QT-interval prolongation and cutaneous rash.

The incidence of atrial fibrillation is growing worldwide in relation to aging populations. It is emerging as a public health concern and affects about 4.5 million people and represents one-third of hospitalizations for arrhythmia in the European Union.

Multaq recently received approval from the U.S. Food and Drug Administration (FDA), Health Canada and Swissmedic (Swiss Health Authority).

www.dronedarone-atrial-fibrillation-pressoffice.com

Related Content

Biotronik Announces U.S. Launch of Edora HF-T QP CRT Pacemaker
Technology | Cardiac Resynchronization Therapy Devices (CRT)| August 21, 2017
Biotronik announced U.S. Food and Drug Administration (FDA) approval and commercial availability of Edora HF-T QP, an...
Medtronic Announces Global Resolute Onyx DES One-Month DAPT Study
News | Antiplatelet and Anticoagulation Therapies| August 18, 2017
Medtronic plc announced a global randomized clinical trial that will evaluate one-month dual antiplatelet therapy (DAPT...
The FDA is concerned about cybersecurity of ICDs and cyber security of other medical devices.
Feature | Cybersecurity| August 16, 2017 | Dave Fornell
There is growing concern among patients and regulators that medical devices, especially implantable electrophysiology
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems| August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
Abbott Initiates XIENCE Short DAPT Clinical Trial
News | Antiplatelet and Anticoagulation Therapies| August 03, 2017
Abbott recently announced the first patient has been enrolled in a clinical study evaluating the short-term use of...
Merge Hemo cath lab hemodynamics monitoring system.

Hemodynamic data shown on screens from the Merge Hemo recording system. It is among the newer generation hemodynamic systems for cath labs that are more user friendly and have technologies to speed workflow.

Feature | Hemodynamic Monitoring Systems| August 03, 2017 | Dave Fornell
The current generation of...
Left Atrial Pressure Monitor from Vectorious Medical Technologies Offers New Hope for Heart Failure Patients

On of the top stories in July was the introduction of a left atrial pressure monitor from Vectorious Medical Technologies to prevent heart failure patient hospitalizations or readmissions. Read the article"Left Atrial Pressure Monitor Offers New Hope for Heart Failure Patients."

Feature | August 01, 2017 | Dave Fornell
Aug.
Ohio State Researchers Prove Human Heart's 'Battery' Has Multiple Backups
News | EP Lab| July 27, 2017
July 27, 2017 — There is good news when it comes to the heart’s sinoatrial node (SAN), the body’s natural...
Overlay Init