Sanofi halts Ketek trials in children

French drug major Sanofi-Aventis has suspended pediatric trials of its antibiotic Ketek (telithromycin), reports the Wall Street Journal. A spokesperson from the company told the newspaper that enrollment had been halted but stressed that it was not at the request of the US Food and Drug Administration.

The first-in-class ketolide antibiotic is approved for certain respiratory tract infections in adults aged over 18 but its path to US registration was beset with problems, involving two approvable letters and two meetings of the FDA's Anti-Infective Drugs Advisory Committee. First submitted in 2000, it was recommended for approval by the panel at a meeting the following year but for only one of three proposed indications and with reservations about safety.

Sanofi-Aventis, the world's third-largest drugmaker, filed a complete response in 2002 after conducting a 24,000-patient study to provide additional data on Ketek's efficacy against resistant bacterial strains and to answer questions on its hepatic safety. At a second advisory committee meeting, the agency requested label warnings about liver and cardiac side effects, as well as a caution about its potential to cause blurred vision.