FDA Approves Merck's PREVYMIS for Prevention of CMV

Merck & Co., Inc. has announced early this morning that PREVYMIS, or letermovir, has just received approval from the US Food and Drug Administration (FDA) to be administered orally via once-daily tablets and through injection for intravenous use.

PREVYMIS will be used as a preventive tool against cytomegalovirus (CMV) infection and disease “in adult CMV-seropositive recipients (R+) of an allogeneic hematopoietic stem cell transplant (HSCT),” according to a recent article.

Just last month, Contagion^® covered the potential of letermovir, a first-in-class inhibitor of the terminase complex CMV, reporting the good news that was gleaned from the randomized, double-blind placebo-controlled trial (NCT02137771) that had been presented in a poster session at ID Week 2017 in San Diego, California. The study showed that letermovir protected against viral infection in CMV-seropostive individuals following HSCT.

One big aspect of HSCT is immunosuppression, and, despite the fact that it “paves the way for transplant success,” it can also leave patients vulnerable to potentially life-threatening infections, such as CMV. Roy F. Chemaly, MD, MPH, infectious disease specialist from the University of Texas MD Anderson Cancer Center in Houston, Texas, participant in told Contagion^® in an exclusive interview, “CMV is one of the most common infections we see after transplant. In high-risk transplant patients, the rate can be upwards of 80%, with rates of 35% to 40% in lower-risk patients.” You can watch the clip below to see what Dr. Chemaly feels letermovir brings to the table:

The recommended dosage of PREVYMIS, or letermovir, is 480 mg administered once daily, given as early as Day 0 and up to Day 28 post-transplantation. “If PREVYMIS is co-administered with cyclosporine, the dosage of oral or intravenous PREVYMIS should be decreased to 240 mg once daily. PREVYMIS is available as 240 mg and 480 mg tablets, which may be administered with or without food. PREVYMIS is also available as 240 mg and 480 mg injection for intravenous infusion via a peripheral catheter or central venous line at a constant rate over one hour,” according to the press release.

PREVYMIS is expected to be available in December—the list price for the tablets is $195.00, $270.00 for injection.