Relenza zanamivir inhaled neuraminidase inhibitor regulatory update

BTA partner GLXO withdrew its NDA for Relenza to prevent influenza A and B infection in adults. GLXO said the FDA requested additional efficacy data for the product, which GLXO plans to obtain this winter from ongoing clinical trials. GLXO previously withdrew its MAA for the prevention indication for Relenza in order to resubmit the application along with additional requested clinical data (see BioCentury, June 5). Relenza is approved in the U.S. and Europe to treat influenza infection. ...