Posted by Michael Wonder on 15 Nov 2020
CHMP recommends EU approval of Roche’s Xofluza (baloxavir marboxil) for the treatment of influenza
13 November 2020 - One-dose, oral Xofluza has been recommended for approval for the treatment of uncomplicated influenza in patients aged 12 years and above.
Roche today announced that the EMA CHMP has recommended the approval of Xofluza (baloxavir marboxil) for the treatment of uncomplicated influenza in patients aged 12 years and above. In addition, Xofluza has been recommended for approval as a preventive treatment (post-exposure prophylaxis) of influenza in individuals aged 12 years and above.
The CHMP recommendation is based on the results of the phase III CAPSTONE-1, CAPSTONE-2 and BLOCKSTONE studies.
