The FDA today approved letermovir tablets and injection, the first treatment indicated for cytomegalovirus prophylaxis in adults who have been exposed to cytomegalovirus and underwent an allogeneic hematopoietic stem cell transplant.
More than 27,000 allogenic HSCTs are performed each year worldwide, including 8,500 in the United States. An estimated 65% to 80% of these recipients have been previously exposed to cytomegalovirus (CMV) and are at high risk for infection.
Without prophylaxis, these patients can experience CMV infection, which can cause serious problems in patients with a weakened immune system.
A randomized controlled trial showed letermovir (Prevymis, Merck) reduced the incidence of CMV infection compared with placebo among patients undergoing allogeneic HSCT.
The most common adverse events included nausea, diarrhea, vomiting, swelling in the arms and legs, cough, headache, tiredness and abdominal pain.
The FDA previously granted this application breakthrough therapy and orphan drug designations.