Shionogi Receives MHLW’s Approval for Xofluza’s sNDA to Treat Post-Exposure Prophylaxis of Influenza Virus Infection

November 30, 2020 Auto Bot approval, MHLW, receives, regulatory, Shionogi, sNDA, Treat, Xofluza 0

Shots:

  • The approval is based on P-III BLOCKSTONE study assessing Xofluza (baloxavir marboxil, 10/20mg) vs PBO in patients in household members aged ≥12yrs. who was living with someone with an influenza infection confirmed by a rapid influenza diagnostic test
  • Result: The proportion of household members who developed influenza (1.9% vs 13.6%); well tolerated with no new safety signals identified
  • Xofluza inhibits the cap-dependent endonuclease in the PA protein and is a single-dose oral treatment for influenza which is different from all other currently available antiviral treatments

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