FDA updates Merck’s label for cytomegalovirus drug to include kidney transplant patients

Merck grabbed another indication for its cytomegalovirus (CMV) treatment Prevymis — this time to prevent CMV disease in adult kidney transplant recipients, following a priority review by the FDA.

The antiviral agent, also known as letermovir, was first approved in 2017 for the prevention of CMV in allogeneic hematopoietic stem cell transplant patients, marking the first new CMV therapy to come along in 15 years, according to Merck. The company purchased worldwide rights to the drug from AiCuris in 2012 in a $500 million-plus deal.

Investigators recruited 589 adult kidney transplant recipients at high risk for the disease because they were CMV-seronegative but received kidneys that were CMV-seropositive for a randomized, double-blinded Phase III trial.

According to Merck, many adults in the United States have CMV antibodies in their blood because of previous exposure or a primary infection with CMV. People with healthy immune systems…
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