Shots:

• The EMA’s CHMP has recommended the approval of Xofluza (baloxavir marboxil) for the treatment of uncomplicated influenza in patients aged ≥12yrs. Xofluza has also been recommended for approval as a preventive treatment (post-exposure prophylaxis) of influenza in individuals aged ≥12yrs.
• The CHMP recommendation is based on the results of the P-III CAPSTONE-1- CAPSTONE-2 and BLOCKSTONE studies. The company is expecting the EC’s final decision in approval in the near future
• Xofluza is the first in a class of antivirals designed to inhibit the cap-dependent endonuclease protein and is available in the US and in several other countries for influenza types A and B

­ Ref: Roche | Image: Roche