21 May 2021 - New drug application based on Phase 3 trial of maribavir which met its primary outcome of superiority compared to conventional anti-viral therapies in transplant recipients with resistant and/or refractory CMV infection.
Takeda today announced that the U.S. FDA has accepted a new drug application for maribavir for the treatment of CMV infection in those that are refractory with or without resistance, in solid organ transplant or haematopoietic cell transplant recipients.