The approval of expanded indication is based on P-III CAPSTONE-2 study assessing Xofluza (40/80mg) vs oseltamivir (75mg bid for 5days) & PBO in people who met CDC criteria for being at high risk of complications from flu aged ≥12yrs.
The P-III CAPSTONE-2 study results: reduction in time to improve flu symptoms compared to PBO (73 vs 102hrs.); similar efficacy with oseltamivir in relation to the duration of symptoms (54 vs 54hrs.); in type B virus patients- time to the improvement of influenza symptoms (75 vs 101hrs.)
Xofluza is the first & only antiviral therapy that inhibits polymerase acidic endonuclease- thus inhibiting the viral replication- was discovered by Shionogi and is being developed and commercialized globally in collaboration with the Roche (Genentech in the US)
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Ref: Roche | Image: Roche
