Roche’s Xofluza (baloxavir marboxil) Receives FDA Approval for Influenza in Patients Aged ≥12 yrs.

Shots:

• The approval is based on P-III CAPSTONE-1 study assessing Xofluza vs PBO or oseltamivir 75 mg (bid for 5days) in the US & Japan (N=1436) and P-II study in otherwise healthy people with the Flu
• P-III CAPSTONE-1 study results: (Xofluza vs PBO): reduction in flu symptoms by >1day (54 hrs vs 80 hrs); (Xofluza vs oseltamivir) duration of symptoms (54 hrs. vs 54 hrs)
• Xofluza PO is a novel single dose, that inhibits polymerase acidic endonuclease. Roche gained WW rights to develop and commercialize Xofluza from Shinogi (Except Japan & Taiwan)

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