Quoted from http://in.reuters.com/article/2011/07/07/sanofi-idINWEB879920110707
Sanofi halts clinical trial of Multaq
PARIS, July 7 | Thu Jul 7, 2011 8:36pm IST
PARIS, July 7 (Reuters) - Sanofi (SASY.PA) is halting a clinical trial studying whether its Multaq drug, which is already approved to help people with temporary irregular heartbeats, was effective in people with a permanent version of the condition.
In a statement on Thursday, Sanofi said it had decided to stop the Phase IIIb trial after it saw a "significant increase in cardiovascular events" in the group of patients taking Multaq. The company said it did not see any side effects in the patients' livers.
"We are notifying regulatory authorities in all countries where the product is approved or under review on this matter," said Sanofi's Chief Medical Officer Jean-Pierre Lehner in a statement.
"We remain committed to Multaq as an essential treatment option for non-permanent AF (atrial fibrillation) patients."
Multaq is currently approved in the European Union for adult clinically stable patients with irregular heartbeat or to lower heart rate. Approximately 400,000 patients have been treated with Multaq worldwide, the company said.