U.S. FDA approves Takeda’s drug for post-transplant CMV infection

(Reuters) – The U.S. Food and Drug Administration said on Tuesday it had approved Takeda Pharmaceutical Co Ltd’s (4502.T) drug for a common type of viral infection occurring in patients after organ transplant.

The infection is caused by a type of herpes virus called cytomegalovirus (CMV) and can have a major negative impact on transplant recipients, including loss of the transplanted organ as well as death.

The FDA said it approved Takeda’s drug Livtencity for use against CMV disease among patients who do not respond to available antiviral treatments.

“Cytomegalovirus infections that are resistant or do not respond to available drugs are of even greater concern,” FDA official John Farley said.

“Today’s approval helps meet a significant unmet medical need by providing a treatment option for this patient population.”

Livtencity works by preventing the activity of an enzyme involved in virus replication. The drug will be commercially available soon, Takeda said.

Takeda Pharmaceutical Co’s logo is seen at its new headquarters in Tokyo, Japan, July 2, 2018. REUTERS/Kim Kyung-Hoon

CMV is one of the most common infections experienced by transplant recipients, with an estimated incidence rate of around 16%–56% in solid organ transplant recipients, the company said.

Reporting by Manojna Maddipatla in Bengaluru; Editing by Anil D’Silva and Krishna Chandra Eluri

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