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 q8dailynews.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from q8dailynews.com Daily Mail and Mail on Sunday newspapers.
FDA Advisory Committee Recommends Use of Investigational Drug Maribavir (TAK-620) to Treat Post-Transplant Recipients with Cytomegalovirus (CMV) Infection and Disease Refractory to Treatment With or Without Resistance q8dailynews.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from q8dailynews.com Daily Mail and Mail on Sunday newspapers.
Department of Error thelancet.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from thelancet.com Daily Mail and Mail on Sunday newspapers.
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