Letermovir (Prevymis) Okayed for Stem Cell Transplant Infection

November 09, 2017

The US Food and Drug Administration (FDA) yesterday approved letermovir (Prevymis, Merck) to help prevent cytomegalovirus (CMV) infections and disease in adults previously exposed to the common virus who have received an allogeneic hematopoietic stem cell transplant (HSCT), otherwise known as a bone marrow transplant.

Administered by tablet or injection, letermovir is the first drug okayed for this indication, according to an FDA new release. It be longs to a new class of non-nucleoside CMV inhibitors that prevent the virus from replicating.

In allogeneic HSCTs, stem cells are derived from another person's bone marrow, as opposed to the patient's own. The FDA puts the number of allogeneic HSCTs performed each year at more than 27,000 worldwide; roughly 8500 are performed each year in the United States.

From 65% to 80% of patients who receive an allogeneic HSCT have been previously exposed to CMV. Because such HSCT patients may receive immunosuppression therapy to prevent their bodies rejecting the transplant, they are at high risk for a CMV infection, which increases the risk for transplant failure and death. Full-blown CMV disease can affect almost every organ and lead to pneumonia, hepatitis, encephalitis, myelitis, and other serious conditions.

The FDA determined that letermovir was safe and effective on the basis of a randomized, placebo-controlled clinical trial involving 565 patients who had received an HSCT. Those treated with letermovir experienced a lower rate of CMV infection than those who were given placebo, according to the FDA.

Nausea, diarrhea, vomiting, swelling in the arms and legs, cough, and headache were among the most common adverse events observed in the trial. Letermovir is contraindicated in patients receiving pimozide, ergot alkaloids, and pitavastatin or simvastatin when either is administered with cyclosporine.

More information on letermovir is available on the FDA website.

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