U.S. Food & Drug Administration Grants Priority Review of Maribavir

Takeda Pharmaceutical Company Limited announced that the U.S. Food & Drug Administration (FDA) has accepted a New Drug Application (NDA) for maribavir for the treatment of CMV infection in those that are refractory with or without resistance (R/R), in solid organ transplant (SOT) or hematopoietic cell transplant (HCT) recipients.

This is an inflection year for Takeda’s pipeline with up to six regulatory submissions and four potential approvals anticipated by the end of fiscal year 2021. The maribavir NDA acceptance is Takeda’s fourth new molecular entity accepted for regulatory review in six months.

“CMV is one of the most common viral infections experienced by transplant recipients, and current antiviral treatment options are limited, and physicians have to engage in a careful balance of viral clearance and side effect management that can impact patient care and transplant outcomes,” said Obi Umeh, MD, Vice President and Maribavir Global Program Leader, Takeda.

“CMV infection puts transplant recipients at an increased risk of disease, such as pneumonia or gastrointestinal disease. It can also increase the risk of graft rejection, opportunistic co-infections, and in some cases, even death,” said Michael Boeckh, M.D., Ph.D., Head, Infectious Disease Sciences Program at the Vaccine and Infectious Disease Division, Fred Hutch “The results of the SOLSTICE trial are promising and show that maribavir may help with post-transplant CMV viremia, including cases of drug-resistance for which there is an unmet need.”

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