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

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

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

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

Related post