Livtencity (maribavir), an antiviral from Japanese drugmaker Takeda (TYO: 4502), has won an approval from the US Food and Drug Administration (FDA).
The approval is for the treatment of adults and pediatric patients aged 12 years of age or older and weighing at least 35 kg, with post-transplant cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir, or foscarnet.
Ramona Sequeira, president, US Business Unit and Global Portfolio Commercialization, Takeda, said: “Today’s announcement redefines the management of post-transplant CMV with the approval of the first and only treatment for transplant patients with CMV that is refractory with or without resistance, a significantly underserved and vulnerable patient community.
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