Glaxo Wellcome has withdrawn its European licence submission for the prophylactic use of zanamivir (Relenza) for influenza. In a recent statement, the company says that this is because it "wishes to include data from further studies" and that "the regulatory authorities advised Glaxo Wellcome that this would not be possible within the original submission."
Zanamivir is to be assessed by the National Institute of Clinical Excellence (NICE) later this year following last year's interim appraisal. Glaxo Wellcome says that a full submission for the product's use in the treatment of influenza, containing previously submitted data as well as additionally requested data in the elderly and at-risk patients, has been sent to the NICE. The company expects the outcome of the full review before the next influenza season.