Roche has withdrawn the European licence application for its antiviral drug oseltamivir.
The decision, announced on May 26, follows a request for further data to answer questions raised by the Committee for Proprietary Medicinal Products (CPMP). The company says that withdrawal of the application allows it "the opportunity to provide this information to European regulatory authorities" and adds that the application will be "resubmitted as soon as possible". A spokeswoman for Roche told The Journal on May 31 that she was unable to say exactly when that would be.
Like Glaxo-Wellcome's zanamivir, oseltamivir is a neuraminidase inhibitor which is being developed for the treatment of influenza.
In a recent study published in the Lancet (2000;355:1845), oral oseltamivir reduced the duration of influenza by up to 40 per cent in a group of unimmunised healthy adults. The study authors, Dr Karl Nicholson (infectious disease unit, Leicester Royal infirmary) and colleagues, concluded: "The efficacy, tolerability, and ease of administration warrant further investigation in children, elderly patients, and at-risk patients."