Takeda Says FDA Grants Priority Review Of Maribavir For Treatment Of CMV Infection - Quick Facts

(RTTNews) - Takeda Pharmaceutical Company Limited (TAK) 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 hematopoietic cell transplant recipients.

Takeda noted that its NDA is 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.

Maribavir has been granted Orphan Drug Designation for treatment of clinically significant CMV viremia and disease in at-risk patients and also Breakthrough Therapy Designation as a treatment for CMV infection and disease in transplant patients resistant or refractory to prior therapy.