Positive CHMP opinion for maribavir for the treatment of adults with post-transplant cytomegalovirus refractory (with or without resistance) to prior therapies
Takeda announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of maribavir for the treatment of cytomegalovirus (CMV) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult patients who have undergone a hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT)
The European Commission (EC) will consider the CHMP positive opinion and decide upon potential marketing authorization in the coming months. If approved, maribavir would be the first inhibitor of CMV-specific UL97 protein kinase in the European Union (EU) for this indication. The positive opinion from the CHMP was based on the SOLSTICE trial, which evaluated the safety and efficacy of maribavir versus conventional antiviral therapies—ganciclovir, valganciclovir, foscarnet or cidofovir—for the treatment of patients with CMV infection refractory, with or without resistance
“Post-transplant care is critical for transplant recipients, and CMV infection can jeopardize successful outcomes for patients,” said Daniel Curran, Head, Rare Diseases Therapeutic Area, Takeda. “The CHMP positive opinion on the marketing authorization of maribavir is a positive step toward redefining the CMV treatment landscape for transplant patients and their healthcare providers across Europe and toward addressing a great unmet need for this community.”
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