FDA grants priority review to maribavir for refractory cytomegalovirus infection
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The FDA granted priority review to maribavir for the treatment of patients with transplant-associated cytomegalovirus infection that was resistant or refractory to prior treatment, according to the agent’s manufacturer.
Maribavir (TAK-620, Takeda) — an orally bioavailable anti-cytomegalovirus (CMV) compound that targets and inhibits the UL97 protein kinase and its substrates — is the only antiviral agent currently in phase 3 development for CMV infection following transplant. It is under investigation for patients who underwent solid-organ transplant or hematopoietic stem cell transplant.
Estimated incidence of CMV infection ranges from 16% to 56% of solid-organ transplant recipients and 30% to 70% of HSCT recipients.
The FDA’s decision was based, in part, on data from the multicenter, randomized phase 3 SOLSTICE trial, which included solid-organ transplant or HSCT recipients with CMV infection refractory, with or without resistance, to one or more conventional antiviral therapies, including ganciclovir, valganciclovir, foscarnet or cidofovir.
Researchers randomly assigned patients 2:1 to 400 mg maribavir (n = 235) or investigator-assigned treatment (n = 117) for an 8-week period with 12 weeks of additional follow-up.
The trial met its primary endpoint of superiority in clearance of CMV viremia with maribavir compared with investigator-assigned treatment at the end of week 8.
“CMV infection puts transplant recipients at an increased risk [for] disease, such as pneumonia or gastrointestinal disease. It can also increase the risk [for] graft rejection, opportunistic co-infections and, in some cases, even death,” Michael Boeckh, MD, PhD, head of the infectious disease sciences program of the vaccine and infectious disease division at Fred Hutch, said in a press release. “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.”
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