Takeda: Maribavir Gets Positive CHMP Opinion To Treat Post-transplant Cytomegalovirus Refractory

Takeda Pharmaceutical Co. Ltd. (TAK) announced Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP has recommended the approval of maribavir to treat adults with post-transplant Cytomegalovirus or CMV Refractory (With or Without Resistance) to prior therapies.

CMV is one of the most common infections experienced by transplant patients. In transplant recipients, reactivation of CMV can lead to serious consequences including loss of the transplanted organ and can be fatal in extreme cases. Existing therapies to treat post-transplant CMV infections may demonstrate serious side effects that require dose adjustments or may fail to adequately suppress viral replication.

Maribavir, an orally bioavailable anti-CMV compound, is the first and only antiviral agent that targets and inhibits the pUL97 protein kinase and its natural substrates.

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.

The recommendation is for the treatment of 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 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 for this indication.

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