Sanofi-Aventis’ controversial antibiotic Ketek is to remain on the US market as a treatment for pneumonia but the company will no longer be able to promote the drug for sinusitis or bronchitis.
After a two-day hearing, a US Food and Drug Administration joint advisory committee said it recognised the positive benefit-risk profile and recommended continued marketing of Ketek (telithromycin) in mild to moderate community-acquired pneumonia but promotion of the drug in acute exacerbation of chronic bronchitis and acute bacterial sinusitis is to stop, after a review of recent reports connecting the treatment with liver failure.
The committee voted 17-2 against continued marketing for the latter two conditions and some panel members called for a ‘black box’ warning. The French drugmaker said that it appreciated the “open discussion” that took place around the drug and added that it would discuss the recommendations with the FDA.
The limited backing for the drug is the latest chapter in a long-running saga over the safety of Ketek. It was denied approval by the FDA in 2001 and 2003 after the agency asked for more information about its safety, but finally made it to market in 2004. However the agency has come under repeated fire from US politicians who have claimed that a major safety trial of Ketek used to support approval had “data integrity problems.”
Adverse publicity has continued to plague the drug and Sanofi has not released sales information about Ketek since the third quarter of 2005, when it posted a 7.3% decline in turnover to 38 million euros. It is a minor product for the company now despite once being hyped as a potential blockbuster.
Le Fur is to be new CEO
Meantime, Sanofi has confirmed that it has decided to separate the post of chairman and chief executive into two jobs, naming research director Gerard Le Fur as its new CEO. Jean-Francois Dehecq retains his post as chairman having held both posts for 18 years.
