The Food and Drug Administration (FDA)’s Antimicrobial Drugs Advisory Committee voted unanimously to recommend the use of maribavir for the treatment of refractory cytomegalovirus (CMV) infection and disease with or without genotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir in transplant recipients.
Maribavir is an orally bioavailable anti-CMV compound that targets and inhibits the UL97 protein kinase and its natural substrates. The recommendations were based on data from the phase 2 (ClinicalTrials.gov Identifier: NCT01611974) and phase 3 (ClinicalTrials.gov: NCT02931539) TAK-620-303 (SOLSTICE) trials.
The phase 3 trial included 352 patients aged 12 years and older who were recipients of hematopoietic stem cell or solid organ transplant and were refractory or resistant to prior anti-CMV treatment. Findings from the trial showed maribavir demonstrated greater confirmed CMV viremia clearance compared with conventional therapy. Moreover, a greater proportion of patients in the maribavir arm maintained CMV viremia clearance and symptom control compared with those in the conventional therapy arm.
The New Drug Application for maribavir is currently under Priority Review by the FDA.
“Today’s vote in favor of our investigational antiviral drug marks a significant step towards delivering the first approved treatment for adult transplant recipients with refractory CMV infection and disease, with or without resistance,” said Obi Umeh, MD, Vice President and Maribavir Global Program Leader at Takeda. “We look forward to working with the FDA as it completes its review of our application.”
FDA Advisory Committee recommends use of investigational drug maribavir (TAK-620) to treat post-transplant recipients with cytomegalovirus (CMV) infection and disease refractory to treatment with or without resistance. News release. Takeda Pharmaceutical Company Limited. Accessed October 8, 2021. https://www.businesswire.com/news/home/20211007006064/en/FDA-Advisory-Committee-Recommends-Use-of-Investigational-Drug-Maribavir-TAK-620-to-Treat-Post-Transplant-Recipients-with-Cytomegalovirus-CMV-Infection-and-Disease-Refractory-to-Treatment-With-or-Without-Resistance.