Takeda Pharmaceutical announced results from a phase 3 clinical trial evaluating the efficacy and safety of the investigational drug TAK-620 (maribavir), in the treatment of transplant recipients with refractory/resistant cytomegalovirus (CMV) infection.
While CMV commonly affects much of the population without causing symptoms, it can cause serious disease in individuals with compromised immune systems, which includes patients who received immunosuppressants associated with various types of transplants.
19 years after entering the clinic, maribavir has finally proven effective in a late-stage study. Originally developed by Shire and acquired in Takeda's $80 billion 2019 takeover, the drug was granted breakthrough therapy status in Jan. 2018.
According to Takeda, the SOLSTICE trial met its primary endpoint, defined as the proportion of patients who achieved confirmed CMV viremia clearance compared to the investigator assigned treatment after 8 weeks. In addition, the SOLSTICE trial met its key secondary endpoint, defined as achievement of CMV viremia clearance and symptom control at end of week 8, and maintained through week 16.
If approved, Takeda says maribavir has the potential to redefine management of post-transplant CMV infections by helping patients clear the virus with less treatment limiting toxicities.
Read the press release
