It is the first CMV drug to be approved in the US in 15 years.
The US Food and Drug Administration (FDA) has approved letermovir (PREVYMIS) tablets for once-daily oral use, as well as the injection formula for intravenous infusion, for the prevention of cytomegalovirus (CMV) infection and disease in adults CMV-seropositive recipients (R+) of an allogeneic hematopoietic stem cell transplant (HSCT).
The decision was made based on data from a phase 3 trial in which a significantly fewer amount of subjects developed a clinically significant CMV infection or discontinued treatment when treated with letermovir (38%, n = 122/325) compared with placebo (61%, n = 103/170; P <.0001). The 24-week study period also revealed that all cause mortality was lower in patients receiving letermovir (12%) than placebo (17%).
“Our findings demonstrate that letermovir is a significant and welcomed advance in the prevention of clinically significant CMV infection and lowers mortality in this highly vulnerable patient population,” said Francisco M. Marty, MD, an associate professor of medicine at Harvard Medical School and an attending physician in transplant and oncology infectious diseases at the Dana-Farber Cancer Institute and Brigham and Women’s Hospital, in a statement.
The recommended dose of letermovir was set at 480 mg, given up to Day 28 post-transplantation starting from Day 0, administered once daily. The drug can be continued until Day 100 post-transplantation. It is also available in 240 mg, to be used with co-administered cyclosporine.
“PREVYMIS continues Merck’s longstanding tradition of bringing forward important new therapies to address serious infectious diseases,” Roy Baynes, MD, PhD, the senior vice president, head of clinical development, and chief medical officer at Merck Research Laboratories said in a statement. “We are proud to add this breakthrough medicine to our existing offerings for physicians and patients.”
The Merck product is contradicted in patients that receive pimozide, as increased concentrations can reportedly lead toQT prolongation, as well as in patients that receive ergot alkaloids, as it may lead to ergotism. The drug is also contradicted in patients on pitavastatin or simvastatin co-administered with cyclosporine.
The most common adverse events (AEs) for patients given letermovir were cardiac in nature, with tachycardia reported in 4% of patients, and atrial fibrillation in 3% of patients. The events were considered mild or moderate in terms of severity. AEs occurring in at least 10% of patients on letermovir were nausea, diarrhea, vomiting, peripheral edema, couch, headache, fatigue, and abdominal pain.
The drug is the first new therapy for CMV in the US to be approved in more than a decade and is expected to hit the market in December.