Sanofi Aventis' Multaq recommended for approval in the EU

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a positive opinion recommending marketing authorization in the European Union for French drug major Sanofi-Aventis' Multaq (dronedarone - 400mg Tablets). The drug was approved for use in the USA in July, and more recently by Health Canada and Swissmedic.

The CHMP has recommended the approval of Multaq 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 hospitalizations. The positive opinion from the CHMP needs now to be ratified by the European Commission.

Sanofi-Aventis, which has previously forecast peak annual sales of the drug at around $1.4 billion, 'welcomes the positive CHMP recommendation for the approval of Multaq in the European Union," said Jean-Pierre Lehner, chief medical officer at 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 will contribute to fulfill significant unmet medical needs for the patients," he added.

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.

The ATHENA trial involved 4,628 patients with atrial fibrillation/atrial futter or a recent history of these conditions and showed that Multaq, in addition to standard therapy, reduced the combined endpoint of cardiovascular hospitalization or death from any cause by 24% (p<0.001) 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 EU, the drugmaker notes.