U.S. FDA grants priority review of maribavir for the treatment of post-transplant recipients with cytomegalovirus infection in those resistant and/or refractory to prior anti-CMV treatment

Takeda

21 May 2021 - New drug application based on Phase 3 trial of maribavir which met its primary outcome of superiority compared to conventional anti-viral therapies in transplant recipients with resistant and/or refractory CMV infection.

Takeda today announced that the U.S. FDA has accepted a new drug application for maribavir for the treatment of CMV infection in those that are refractory with or without resistance, in solid organ transplant or haematopoietic cell transplant recipients.

Read Takeda press release

Michael Wonder

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Michael Wonder

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Medicine , US , Priority review , Dossier