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Takeda Pharmaceutical Company Limited
U.S. Food & Drug Administration Grants Priority Review of Maribavir for the Treatment of Post-Transplant Recipients With Cytomegalovirus Infection in Those Resistant and/or Refractory to Prior Anti-CMV Treat
Saturday, May 22, 2021 10:31AM IST (5:01AM GMT)
 
Osaka, Japan:
 
 − If Approved, Maribavir Will Be the First and Only Treatment Indicated for Post-Transplant Cytomegalovirus (CMV) Infection in Those That Are Refractory, With or Without Resistance (R/R)
− NDA based on Phase 3 Trial of Maribavir Which Met Its Primary Endpoint of Superiority Compared to Conventional Antiviral Therapies in Transplant Recipients with R/R CMV Infection
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− The U.S. Food & Drug Administration Granted Maribavir Breakthrough Therapy Designation as a Treatment for CMV Infection in Transplant Patients Resistant or Refractory to Prior Therapy ....

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