July 7, 2011

Sanofi Provides Multaq® Phase IIIb PALLAS Trial Update

- Indication seeking trial in permanent AF patient population stopped -
- Benefit-risk of Multaq remains unchanged in non-permanent AF patients -

 

Sanofi Provides Multaq® Phase IIIb PALLAS Trial Update
- Indication seeking trial in permanent AF patient population stopped -
- Benefit-risk of Multaq remains unchanged in non-permanent AF patients -

Paris, France – July 7, 2011 – Sanofi (EURONEXT: SAN and NYSE: SNY) announced today that the company has discontinued the PALLAS Phase IIIb trial in patients with permanent Atrial Fibrillation (AF), a population different from the population with non-permanent AF for which Multaq® (dronedarone) is currently approved. The decision follows recommendations from the study’s Operations Committee and the Data Monitoring Committee (DMC) which observed a significant increase in cardiovascular events in the dronedarone arm. The decision to terminate the study was not related to any hepatic adverse event.