The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of letermovir for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).1
Prof Karl Peggs, Honorary Consultant in Haematology/Transplantation at UCL Hospitals, comments “I am encouraged to hear that letermovir has been granted a positive CHMP opinion. For far too long we’ve been trying to juggle the toxicities of older drugs. Letermovir offers an opportunity to reduce the CMV-related treatment burden. This is great news both for the treating physicians and the patients we treat.”
“For patients undergoing an allogeneic haematopoietic stem cell transplant, complications arising from cytomegalovirus infection can be life threatening,” said Dr Mike England, MSD UK Medical Director. “We are pleased with the CHMP’s positive opinion recommending the marketing authorisation of letermovir in the European Union, which marks a significant step forward in the regulatory process as we hope to bring this product to patients in the United Kingdom.”
The CHMP positive opinion will be considered by the European Commission. If the European Commission affirms the CHMP opinion, it will grant a centralised marketing authorisation with unified labelling that is valid in the 28 countries of the European Union, as well as European Economic Area members, Iceland, Liechtenstein and Norway.
Pending receipt of marketing authorisation, letermovir will be made available as a concentrate for solution for infusion and as film-coated tablets (240mg and 480mg).1
The US Food and Drug Administration approved letermovir once-daily tablets for oral use and injection for intravenous infusion in November 2017.
- EMA Summary of Opinion, Letermovir (2017), available at: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004536/WC500238077.pdf [Accessed 13 Nov. 2017]