FDA Grants Priority Review for Post-Transplant Cytomegalovirus Infection

By Adam Hochron
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The FDA has granted priority review to a new drug application for maribavir to treat post-transplant cytomegalovirus (CMV) infection in those that are refractory, with or without resistance, to prior therapy in solid organ transplant or hematopoietic cell transplant recipients. 

A press release from the manufacturer described maribavir as an investigational orally bioavailable anti-CMV compound. The application is based on results from the phase 3 SOLSTICE trial. Patients enrolled in the trial were randomized to receive maribavir or investigator assigned treatment, defined as conventional antiviral therapy, including ganciclovir, valganciclovir, foscarnet, or cidofovir. The trial included a 2-week screening period, followed by 8 weeks on the assigned treatment, and 12 weeks of follow-up. 

The primary endpoint of the trial was defined as the proportion of patients who achieved confirmed clearance of CMV viremia (plasma CMV DNA <137/IU/mL in two consecutive tests ≥ 5 days apart at central laboratory) compared to the investigator assigned treatment at the end of the study’s eighth week. The secondary endpoint was the achievement of CMV viremia clearance and symptom control after 8weeks and maintained through week 16. 

Results of the trial were presented at the 2021 Transplantation & Cellular Therapy Meetings Digital Experience. Subgroup analysis was presented during the Presidential Symposium 47th Annual Meeting of the European Society for Blood and Marrow Transplantation.

“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,” Obi Umeh, MD, Vice President and Maribavir Global Program Leader at Takeda, said in the release. “If approved, maribavir has the potential to change the treatment landscape for post-transplant CMV, and the acceptance of this regulatory application is an important milestone on maribavir’s path forward.”

Maribavir was previously granted Orphan Drug Designation by the FDA to treat clinically significant CMV viremia and disease in at-risk patients. It was also granted Breakthrough Therapy Designation to treat CMV infection and disease in transplant patients resistant or refractory to prior therapy. 

The release noted that there is no timeframe for possible approval of the application.

 

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