Japanese pharmaceutical major Takeda has announced that the European Commission (EC) has granted marketing authorisation to its antiviral drug, maribavir, marketed under the name Livtencitytm for the treatment of cytomegalovirus (CMV) infections.

In a communiqué, Takeda said that maribavir has also been authorised to treat infections that fail to respond to treatments to various antivirals, including ganciclovir, valganciclovir, cidofovir or foscarnet, in adult patients who have undergone organ and stem cell transplantation, known as haematopoietic stem cell transplant (HSCT).

“The European Society for Organ Transplantation (ESOT) understands that the transplant patient journey extends well beyond the transplant itself. When not successfully treated, CMV poses a challenge to transplant recipients and their physicians and often leads to increased organ rejection, higher hospitalisation rates, and greater burden on healthcare resources, contributing to inequities for patients across the system,” ESOT President Dr Luciano Potena, said.

“The approval of Livtencity by the EC recognises the need for a new antiviral approach for managing CMV infection that is refractory (with or without resistance) to one or more prior CMV therapies,” he added.

Available data suggest that CMV is one of the most common infections experienced by transplant patients with a global estimated incidence rate of 16-56% in Solid Organ Transplantation and 30-80% in HSCT recipients.

Pointing out that patients who receive a transplant can face a difficult journey on the road to recovery that involves medicines to suppress their immune system, the President of the Global Portfolio Division at  Takeda, Ramona Sequeira said that the authorisation will enable it to offer healthcare providers in the EU and EEA with an additional oral antiviral treatment for post-transplant refractory CMV

The drug has already been approved by the regulatory bodies in the United States, Canada and Australia, the communiqué added.