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36611011000001100

New Medicines

PrevymisProphylaxis of cytomegalovirus (CMV) infections in kidney transplant patients

Information

Prevymis
Licence extension / variation
Merck Sharp & Dohme (MSD)
Merck & Co (name used in US for MSD)

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Yes
Yes

Category

Non-nucleosidic human cytomegalovirus replication inhibitor
Human cytomegalovirus is the most common virus pathogen in solid organ transplant recipients (kidney, heart, liver, lung and pancreas) and bone marrow transplant recipients. It is the major cause of morbidity and mortality during the first 6 months after transplantation. The number of patients with impaired cell-mediated immunity at risk of CMV disease is ~ 3.1 people in 10,000 in the EU - equivalent to ~ 157,000 people.
Prophylaxis of cytomegalovirus (CMV) infections in kidney transplant patients
Oral

Evidence based evaluations