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FDA Approves Letermovir to Prevent Cytomegalovirus Infection in Patients Who Receive HSCT

By: Sarah Jackson
Posted: Friday, November 10, 2017

On November 9, 2017, the U.S. Food and Drug Administration (FDA) approved letermovir (Prevymis) to prevent cytomegalovirus (CMV) infections and disease in adults previously exposed to the virus who have received allogeneic hematopoietic stem cell transplant (HSCT). Administered by tablet or injection, letermovir belongs to a new class of non-nucleoside CMV inhibitors that prevents viral replication by specifically targeting the viral terminase complex.

CMV is a common and potentially serious viral infection in recipients of HSCT. Any level of CMA infection may be associated with increased mortality in this patient population.

The approval of letermovir is based on a randomized phase III trial involving 565 patients who underwent HSCT. Those treated with letermovir experienced a lower rate of CMV infection compared with the control group receiving only placebo. All-cause mortality in those receiving letermovir was lower than in those receiving placebo (12% vs 17%) at week 24 post-transplant.

The cardiac adverse event rate was higher in patients receiving letermovir than placebo (13% vs 6%), with the most common cardiac adverse events reported being tachycardia and atrial fibrillation. The most common adverse events associated with letermovir are nausea, diarrhea, vomiting, peripheral edema, cough, headache, fatigue, and abdominal pain.