EMA recommends approval of letermovir for CMV in stem cell transplant recipients

Access to the full content of this site is available only to registered healthcare professionals. Register to read more

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation in the European Union (EU) for letermovir (Prevymis), an antiviral that prevents cytomegalovirus (CMV) reactivation and disease in patients receiving immunosuppressant medicines following allogeneic haematopoietic stem cell transplant.

The CHMP recommendation is based on data from a phase 3 clinical trial in which 570 patients who received stem cell transplants in a total of 67 trial centres in 20 countries were randomised to receive letermovir (n=376) or placebo (n=194). The study showed that, 24 weeks after the transplant, 37.5 per cent of patients in the letermovir group (37.5%) developed clinically significant CMV reactivation compared to 60.6 per cent in the placebo group (60.6%).

Letermovir received orphan designation from the Committee for Orphan Medicinal Products (COMP) in June 2012. The orphan designation will now be reviewed to determine whether the information available to date supports maintaining the drug's orphan status and granting 10 years of market exclusivity. The opinion adopted by the CHMP at its November 2017 meeting will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation.