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Heart Problems Halt Multaq Trial

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A clinical trial of the heart drug Multaq is being halted due to increased problems among patients taking the drug, reported Reuters. Sanofi was hoping the trial would result in approval for treatment of irregular heartbeats in patients with a permanent version of the condition. Multaq is currently used to treat patients with temporary irregular heartbeat and has been on the market in the U.S. since early 2010.

Sanofi chose to discontinue the trial after monitoring a “significant increase in cardiovascular events” in certain participants. The company remains confident that Multaq is necessary to treat “non-permanent atrial fibrillation patient,” reported Reuters.

The trial did not observe any liver patients with side effects, which was an issue in January when two patients reported developing side effects after using Multaq.

Sanofi’s decision to pull the trial could result in financial woes for the company since one-third of their 2008 sales base will lose patent protection by 2013. Currently, Multaq is one of their most important new products as it was expected the drug would replace lost revenue caused by generic competition.

It is estimated Multaq will generate $1.35 billion in sales by 2014. The drug has been on the market in Europe since July 2009 and in 2010 generated 172 million euros, or $245 million. In the European Union, Multaq is approved for adult clinically stable patients with irregular heartbeat or lower heart rate.

In January 2011, the U.S. Food and Drug Administration issued a warning that two patients taking Multaq suffered from severe liver injury. The agency issued a black box warning, the most severe warning, stating the drug can cause severe complications in patients with recent severe heart failure.

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