BRUSSELS/FRANKFURT/PARIS (dpa-AFX) - Takeda (TAK) announced the European Commission has granted Marketing Authorization for LIVTENCITY for the treatment of cytomegalovirus infection and/or disease that are refractory to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet, in adult patients who have undergone a haematopoietic stem cell transplant or solid organ transplant. The EC approval marks the fourth approval of LIVTENCITY for post-transplant refractory CMV infection, the company noted.
The centralized marketing authorization was based on the phase 3 SOLSTICE trial, the company said.
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