Merck Receives FDA Approval of its CMV drug Prevymis
The USFDA has now announced the approval of Merck’s Prevymis (letermovir) tablets and injection, the first drug indicated to help prevent CMV (cytomegalovirus) infection and disease in adults who have been exposed to CMV and have received an allogeneic hematopoietic stem cell (bone marrow) transplant (HSCT).
CMV is a common and potentially serious viral infection in allogeneic HSCT recipients. CMV-seropositive patients who undergo an HSCT are at high risk for CMV reactivation. Any level of CMV infection is associated with increased mortality in HSCT patients. CMV prophylaxis with certain existing antivirals has been associated with drug-specific effects, including myelosuppression and renal toxicity, in HSCT recipients.
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, Ph.D., 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.”
Privy is expected to be available in December. The list price (wholesale acquisition cost) per day for Prevymis tablets is $195.00 and for Prevymis injection is $270.00. Wholesaler acquisition costs do not include discounts that may be paid for the product.