Glaxo withdraws Relenza prevention NDA

Glaxo (GLX; LSE:GLXO) withdrew its NDA for Relenza zanamivir, an inhaled neuraminidase inhibitor, to prevent influenza A and B infection in adults. GLX said that the FDA requested additional efficacy data for the product, which it plans to obtain in ongoing clinical trials this winter. GLX 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. Relenza was licensed from Biota (ASX:BTA; BTAHY). ...