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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 1 − 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

United statesFred hutchMichael boeckhRyoko matsumotoMaribavir global program leaderHuman cytomegalovirus nuclear egressInternational report on organ donationTakeda pharmaceutical company limitedStage of nuclear egressTakeda pharmaceutical companyMediates disruption of nuclear laminaInfectious disease divisionEuropean commissionDrug administrationWorld health organizationMeeting of the european society for blood