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Takeda Announces Publication of Data from SOLSTICE, a Pivotal Phase 3 Trial for LIVTENCITY™ (Maribavir) in Post-Transplant Recipients With Cytomegalovirus (CMV) Infection (Refractory, With or Without Resistance)

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the data from the pivotal Phase 3 SOLSTICE clinical trial of LIVTENCITY™ (maribavir, TAK-620) in post-transplant refractory† CMV infections with or without resistance‡ (R/R) were published in the journal of Clinical Infectious Diseases (CID).

Takeda s LIVTENCITYTM (maribavir) Approved by U S FDA as the First and Only Treatment for People Ages 12 and Older with Post-Transplant Cytomegalovirus (CMV), Refractory (With or Without Genotypic Resistance) to Conventional Antiviral Therapies

Takeda s LIVTENCITYTM (maribavir) Approved by U S FDA as the First and Only Treatment for People Ages 12 and Older with Post-Transplant Cytomegalovirus (CMV), Refractory (With or Without Genotypic Resistance) to Conventional Antiviral Therapies
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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 Treatment

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

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