January 21, 2011 / 12:01 PM / 7 years ago

UPDATE 2-EU agency reviews Sanofi's Multaq, backs Jevtana

* EU regulators start review of Multaq amid liver concerns

* Says product information should advise close monitoring

* Sanofi’s prostate cancer drug Jevtana wins EU backing

(Updates throughout after statement on Multaq, adds background)

LONDON, Jan 21 (Reuters) - The European Medicines Agency (EMA) said on Friday it was starting a review of the safety of Sanofi-Aventis’s (SASY.PA) heart drug Multaq 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.

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 Jan. 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. [ID:nLDE70H0WU]

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.

Analysts see Multaq, which won approval from European medicines regulators in September 2009 and was approved in the United States in July 2009, as a key growth driver for Sanofi to see it through patents expiries on multi-billion euro drugs like the cancer treatment Taxotere and the blood thinner Plavix.

Analysts expect sales of Multaq, known generically as dronedarone, to reach $1.35 billion by 2014, according to consensus forecasts from Thomson Reuters. (Reporting by Kate Kelland and Ben Hirschler, editing by Sophie Walker)

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