Merck, known as MSD outside of the United States and Canada, announced that Health Canada has approved a new indication for Prevymis (letermovir) for the prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor CMV-seropositive/Recipient CMV-seronegative [D+/R-]).
Merck Receives Positive EU CHMP Opinion for PREVYMIS® for Prevention of CMV Disease in High-Risk Adult Kidney Transplant Recipients and Extended 200-Day Dosing in Adult HSCT Recipients at Risk for Late CMV Infection and Disease
Merck grabbed another indication for its cytomegalovirus (CMV) treatment Prevymis — this time to prevent CMV disease in adult kidney transplant recipients, following a priority review by the FDA.
RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved a new indication for PREVYMIS® (letermovir) for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor CMV-seropositive/Recipient CMV-seronegative [D+/R-]) following a priority review.
U.S. FDA Accepts for Priority Review the Supplemental New Drug Application for Merck’s PREVYMIS™ for Prophylaxis of Cytomegalovirus Disease in Kidney Transplant Recipients at High Risk
Since it hit the market in 2017 to prevent cytomegalovirus (CMV) infection in stem cell transplant patients, Merck’s Prevymis has racked up steadily increasing sales.
The National Institute for Health and Care Excellence (NICE) has changed its mind and issued a Final Appraisal Document, recommending MSD’s Prevymis (letermovir) for preventing cytomegalovirus (CMV) reactivation and disease after an allogeneic haematopoietic stem cell transplant (HSCT) within the NHS.
Stinging from an initial rebuff last year, Merck hoped for a turnaround from England’s drug-price watchdog for its antiviral drug Prevymis. And thanks to a discount offer, the drugmaker got exactly that.
Once an application has been accepted for evaluation by TGA, the approval time is defined as the number of TGA working days between commencement of evaluation and registration decision. TGA works to business target timeframes as well as to legislated timeframes for each category of application. Approval times are underpinned by legislation (see Therapeutic Goods Regulations 1990) and excludes public holidays, weekends, the time allocated to the sponsor to respond to requests for information, 'mutual clock stop' periods agreed with the sponsor, or other review activities.
Merck Sharp & Dohme`s Prevymis (letermovir) Receives Approval In Europe