Roche’s Xofluza (baloxavir marboxil) Receives the US FDA’s Approval for People at High Risk of Developing Influenza-Related Complications

Roche’s Xofluza (baloxavir marboxil) Receives the US FDA’s Approval for People at High Risk of Developing Influenza-Related Complication

Shots:

  • 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)

Click here to­ read full press release/ article | Ref: Roche | Image: Bloomberg