Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that 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(R) (dronedarone - 400mg Tablets).
The CHMP has recommended the approval of Multaq(R) in adult clinically stable patients with history of, or current non-permanent 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 hospitalisations.
The positive opinion from the CHMP needs now to be ratified by the European Commission.
"Sanofi-aventis welcomes the positive CHMP recommendation for the approval of Multaq(R) in the European Union" said Jean-Pierre Lehner, Chief Medical Officer, sanofi-aventis. "This decision brings new hope to people whose lives are impacted by the potential cardiovascular complications of atrial fibrillation. We do think that Multaq(R) will contribute to fulfill significant unmet medical needs for the patients".
The CHMP positive opinion is based on the submission of a comprehensive clinical data package including seven international, multi-center, randomized clinical trials involving more than 7000 patients and including the landmark ATHENA trial.