Roche wins European approval for Xofluza

11 January 2021

Swiss pharma giant Roche (ROG: SIX) has picked up European approval for Xofluza (baloxavir marboxil), a treatment for flu in people 12 years and over.

The European authorities have also approved Xofluza for post-exposure prophylaxis of influenza. Both decisions come following positive opinions received from a scientific committee of the European Medicines Agency.

The firm submitted to the EMA based on the results of the Phase III CAPSTONE-1, CAPSTONE-2 and BLOCKSTONE studies.

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