Data Include Exploratory Analysis Showing LIVTENCITY Treated Patients With Post-Transplant Cytomegalovirus (CMV) Infections/Disease Had Reductions in Hospitalizations (34.8%; p=0.021) and Length
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).
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.
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
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
OSAKA, Japan (Business Wire)
−
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