Roche’s Xofluza (baloxavir marboxil) Receives the US FDA’s Approval for Post-Exposure Prevention of Influenza

 Roche’s Xofluza (baloxavir marboxil) Receives the US FDA’s Approval for Post-Exposure Prevention of Influenza

Roche’s Xofluza (baloxavir marboxil) Receives the US FDA’s Approval for Post-Exposure Prevention of Influenza

Shots:

  • The approval is based on P-III BLOCKSTONE study assessing a single dose of Xofluza vs PBO in household members who were living with someone with influenza confirmed by a rapid influenza diagnostic test
  • Results: The proportion of household members aged ≥12yrs. who developed influenza (1% vs 13%), well-tolerated with no new safety signals
  • Xofluza is the first single-dose influenza medicine approved to prevent influenza for those who have had contact with an infected person. Roche also plans to file sNDA for Xofluza as a treatment for acute uncomplicated influenza in pediatric patients (1-12yrs.) and for the prevention of influenza in the same age group who have been exposed to influenza

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: BioSpace

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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