Merck Sharp & Dohme (MSD) is closing on European approval for its infection treatment Prevymis (letermovir) after it received backing from the Committee for Medicinal Products for Human Use’s (CHMP) last week.
Prevymis is one of a new class of non-nucleoside inhibitors and aims to prevent cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients of an allogeneic haematopoietic stem cell transplant (HSCT).
Dr Mike England, UK Medical Director, MSD, said: “For patients undergoing an allogeneic haematopoietic stem cell transplant, complications arising from cytomegalovirus infection can be life threatening.”
Once approved, the treatment – which was acquired from German biotech AiCuris – will be available as an injectable and as film-coated tablets at 240mg and 480mg.
CMV is a common virus that can infect people of all ages and many of the infected are CMV seropositive, meaning they have CMV antibodies in their blood, which indicates a previous exposure to or primary infection with CMV.
People with a weakened immune system may give the virus a chance to reactivate, potentially leading to symptomatic disease or a secondary infection due to other pathogens, which can lead to end-organ damage.
In 2014, there were 1,346 non-paediatric allogeneic HSCT procedure performed in the UK and up to 50% of CMV seropositive recipients of allogeneic HSCT experienced CMV reactivation.
Dr England added: “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 US Food and Drug Administration approved letermovir once-daily tablets for oral use and injection for intravenous infusion earlier this month.