The European Medicines Agency (EMA) recently announced that it is expanding the currently ongoing benefit-risk assessment of Sanofi-Aventis’ (SNY) anti-arrhythmic medicine Multaq. The agency said that it intends to review the cardiovascular risk of Multaq.
The decision to expand the scope of the review follows Sanofi’s recent announcement regarding the discontinuation of the PALLAS study. On July 7, Sanofi had announced that it has discontinued the PALLAS phase IIIb trial which was being conducted in patients with permanent atrial fibrillation (AF). Multaq is currently approved for non-permanent AF, a different patient population.
Sanofi decided to discontinue the study based on recommendations from the study’s Operations Committee and Data Monitoring Committee (DMC). A significant increase in cardiovascular events was observed in the Multaq arm. A higher rate of events and hospitalizations were seen in the Multaq arm compared with placebo. Sanofi said that the decision to terminate the study was not related to any hepatic adverse event.
Multaq is already being reviewed by the EMA’s Committee for Medicinal Products for Human Use (CHMP) from January 2011. The CHMP is assessing the overall benefit-risk balance of Multaq following reports of severe liver injury. Now, the CHMP will evaluate new information from the PALLAS study and will determine the need for any further action at its next meeting (July 18-21, 2011).
Earlier, in January 2011, Sanofi-Aventis had issued a Dear Health Care Professional Letter in the US and EU informing health care providers of several cases of hepatocellular liver injury and hepatic failure in patients receiving Multaq, including two post-marketing reports of acute hepatic failure requiring transplantation. Moreover, the FDA had issued a Drug Safety Communication on hepatic events reported in patients treated with Multaq. In February 2011, both the EU Summary of Product Characteristics and US Prescribing Information were updated to include liver function monitoring.
Multaq is currently approved in the EU in adult clinically stable patients with a history of, or current non-permanent AF to prevent recurrence of AF or to lower ventricular rate. About 400,000 patients across the world have been treated with Multaq with sales coming in at €172 million in 2010. Sales could be hampered if additional restrictions are included in the product label.
Neutral on Sanofi
We currently have a Neutral recommendation on Sanofi, which carries a Zacks #3 Rank (short-term “Hold” rating). The company recently completed its acquisition of biotech company Genzyme Corporation. This acquisition will boost Sanofi’s revenues as well as its pipeline.
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