Sanofi-Aventis is celebrating this morning after getting the thumbs-up from European regulators for Multaq, the first new anti-arrhythmic to be approved in the European Union in the last 10 years.

The European Commission has granted marketing authorisation for Multaq (dronedarone), a move that was expected following a positive recommendation in September from the European Medicines Agency’s Committee for Medicinal Products for Human Use. The treatment has been indicated in adult clinically stable patients with a history of, or current non-permanent atrial fibrillation to prevent recurrence of AF or to lower ventricular rate.

The approval is based on a data package including seven clinical trials involving more than 7,000 patients, with almost 4,000 of them receiving Multaq. Notable among the trials was the Athena study, which showed that the drug showed a clinical benefit to reduce cardiovascular hospitalisations or death from any cause in patients with AF and atrial flutter.

Sanofi’s R&D chief Marc Cluzel said the Multaq green light is important news for AF patients “who will now have access to a new treatment approach”. He added that the drug is the result of “more than 15 years of R&D”.

Stefan Hohnloser, principal investigator of the Athena study, noted that AF affects about 4.5 million people in Europe and represents one-third of hospitalisations for arrhythmia in the EU. He claimed that Multaq offers a new treatment option to physicians “in a field where there has been no significant anti-arrhythmic drug innovation for almost 20 years”.

The first launches of Multaq are expected to take place in the UK and Germany in January. It is already approved in the USA, Canada, Switzerland and Brazil.

Russian accord
Meantime, Sanofi has unveiled plans to expand its presence in Russia and manufacture insulin locally.

The French drugmaker is linking up with Prominvest, a subsidiary of state-owned Rostekhnologii, and confirmed its intention to participate in the Pharmpolis Project. The latter is part of a bid by the government in Moscow to expand the country’s pharmaceutical market to “localise innovative drug manufacturers in Russia, to attract high technology platforms” and to provide firms with “sufficient resources, effective business environment and proper supplier network”.

As part of the project, Sanofi will manufacture insulin at its Russian factory as a pilot initiative. Chief executive Chris Viehbacher said “we want to create a situation in which patients suffering from severe conditions, such as diabetes, are diagnosed and treated as early as possible and have access to innovative drugs at affordable prices”. The manufacturing of insulin locally “will be a major step towards achieving this goal”, he added.

Sergei Chemezov, general director of Rostekhnologii said diabetes is “one of the Russian Federation’s three major public health priorities, with high mortality rates and affecting 2.5 million diagnosed. He added that if undiagnosed cases are taken into account, this figure is estimated to be around 10 million people.