CHMP positive for Xofluza, intended for the treatment and post-exposure prophylaxis of uncomplicated influenza.- Roche.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Xofluza, intended for the treatment and post-exposure prophylaxis of uncomplicated influenza. The benefits of Xofluza are its ability to reduce the duration of influenza-related symptoms in healthy individuals and individuals at high risk of influenza-related complications. Following post-exposure prophylaxis with Xofluza, significantly fewer subjects developed symptomatic influenza. No major common side effects were detected in the clinical trials. Hypersensitivity reactions have been observed in the post-marketing setting, including reports of anaphylaxis and less severe hypersensitivity reactions such as urticaria and angioedema.