Ketek recommended for approval in USA, but with disappointing indications

Aventis' novel antibiotic Ketek (telithromycin), the first in a newclass of ketolide antibiotics, has been recommended for only one of three proposed indications by the US Food and Drug Administration's Anti-infective Drugs Advisory Committee. The panel's conclusions come as a massive blow to Aventis' aspirations for the antibiotic, which the firm has tipped as a potential $1 billion drug.

The panel voted to recommend approval of Ketek for the treatment of community-acquired pneumonia (at a dose of 800mg once daily), in patients 18 years of age or older, by a vote of seven to three. However, it said that more data would be required before it could back registration of the drug for use in acute bacterial exacerbation of chronic bronchitis and for acute sinusitis, voting 10 to zero and eight to two, respectively, against these proposed indications.

Analysts at Morgan Stanley Dean Witter note that the recommendation was for a far narrower set of claims than anticipated, and runs counter to the broader recommendations given to the drug by the European Commission's Committee for Proprietary Medicinal Products (Marketletter April 30).