Regulatory

EU agency reviews Sanofi's Multaq, backs Jevtana

Last Updated: 2011-01-24 9:00:04 -0400 (Reuters Health)

By Kate Kelland and Ben Hirschler

LONDON (Reuters) - The European Medicines Agency (EMA) said on Friday it was starting a review of the safety of Sanofi-Aventis's heart drug Multaq (dronedarone) after two cases of liver failure in patients on the drug.

In a separate move, the EU drugs regulator also said it was recommending approval of Sanofi's prostate cancer drug Jevtana (cabazitaxel).

Jevtana is already available in the United States and the French drugmaker said response to the drug there had exceeded its expectations. Recommendations by the agency's Committee for Medicinal Products for Human Use (CHMP) are usually endorsed by the European Commission within a couple of months.

For Multaq, the agency said it was starting a review of the risk-benefit balance of the drug and, as a precautionary measure, advising changes to the product's information to help manage the possible risk of severe liver complications.

Sanofi had said on January 18 it expected the agency to ask for an alert on Multaq as a result of the two cases of liver failure in patients taking the drug.

The CHMP discussed Multaq and "concluded that there was a need for urgent regulatory action to help manage the possible risk of severe liver complications with the medicine," EMA said in a statement.

It recommended that warnings be added to the medicine's prescribing information to ensure that patients' liver function is tested before treatment is started and is then closely monitored. It said the advice should say that treatment should be stopped if there are signs of potential liver damage.

Multaq won approval from European medicines regulators in September 2009 and was approved in the United States in July 2009.