January 14, 2011 / 1:04 PM / 7 years ago

UPDATE 2-Sanofi confirms liver damage in 2 Multaq patients

* Two patients needed liver transplants after taking drug

* Sanofi says no causal link established in the two cases

* Multaq 2014 consensus sales forecasts $1.35 billion

* Sanofi shares down 1.1 percent (Adds U.S. FDA statement, updates share movement)

PARIS, Jan 14 (Reuters) - Sanofi-Aventis (SASY.PA) confirmed on Friday that two patients suffered liver failure after taking its Multaq heart drug, but said no causal link had been established with the medicine.

The French drugmaker, whose shares were down 1.1 percent in Paris trading, said it had informed U.S. healthcare professionals of hepatic failure resulting in liver transplantation in two patients taking Multaq.

The U.S. Food and Drug Administration said it had received “several” reports of liver injury in patients taking Multaq, including the two cases requiring transplants.

In a notice on its website, the agency said it was “continuing to review reports of possible adverse events and drug interactions” with Multaq.

Users of the drug should contact a doctor if they notice signs of liver problems, such as yellowing of the skin, dark urine or loss of appetite, the FDA said. But the agency said patients should not stop taking Multaq unless a doctor tells them to do so.

    The two patients who needed transplants were both women around age 70 whose liver function tested normal before starting the drug, the FDA said. One patient had been taking Multaq for 4.5 months and the other for six months.

    Multaq, which became available in the United States in July 2009 and in Europe early last year, is one of Sanofi’s most important new products. Analysts expect sales of the drug, whose generic name is dronedarone, to reach $1.35 billion by 2014, according to consensus forecasts from Thomson Reuters Pharma.

    Sanofi badly needs successful new drugs to make up for patent losses that will take out roughly a third of its 2008 sales base through to 2013. That is a key reason why it is trying to buying U.S. biotech group Genzyme GENZ.O.

    Genzyme has rejected Sanofi’s hostile offer of $18.5 billion, or $69 per share, as too low but the two sides are now in direct talks. A French newspaper said on Friday that Sanofi might reach a takeover deal that would value Genzyme at around $76 per share. [ID:nLDE70D0E6]

    Multaq was approved in July 2009 for treating abnormal heart rhythms known as atrial fibrillation or atrial flutter. The drug can reduce the risk of hospitalizations for those problems, the FDA said. (Reporting by Noelle Mennella, additional reporting by Ben Hirschler in London and Lisa Richwine in Washington, editing by Kate Kelland)

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