March 27, 2023
Anti-cytomegalovirus chemotherapeutic agent "Valixa® Dry Syrup 5000mg" Approved
for the indication of symptomatic congenital cytomegalovirus infection in Japan
Mitsubishi Tanabe Pharma Corporation (Head Office: Chuo-ku, Osaka; Representative
Director: Hiroaki Ueno; hereinafter, “MTPC”), a member of the Mitsubishi Chemical Group,announced today that MTPC received approval for an additional indication of theanti-cytomegalovirus agent Valixa® Dry Syrup 5000mg (generic name: valganciclovirhydrochloride, hereinafter Valixa® Dry Syrup) for the treatment of symptomatic congenital
cytomegalovirus infection.
For this approval, an investigator-initiated clinical trial (VGCV -1) was conducted by aresearch group of 6 medical institutions (The University of Tokyo Hospital, Nihon University
Itabashi Hospital, Nagoya University Hospital, Fujita Health University Hospital, Kobe
University Hospital, and Nagasaki University Hospital) in children with symptomaticcongenital cytomegalovirus infection. This research was supported by Japan Agency for
Medical Research and Development (AMED) grant, “research on treatment of valganciclovir
for infants with symptomatic congenital cytomegalovirus infection”, under Project for Babyand Infant in Research of healTH and Development to Adolescent and Young adult –BIRTHDAY. The results showed that administration of Valixa® Dry Syrup for 6 months
reduced the amount of cytomegalovirus in the whole blood, and suppressed aggravation ofhearing impairment. This is the first approved drug in the world for the treatment ofsymptomatic congenital cytomegalovirus infection and will provide patients with a newtreatment option.
Symptomatic congenital cytomegalovirus infection is a rare disease that develops whencytomegalovirus is transmitted to the fetus via the placenta of a pregnant woman.
Approximately 1,700 newborns per year develop the disease in Japan. In neonates withsymptomatic congenital cytomegalovirus infection, symptoms such as central nervous
system disorders and deafness are often observed at birth, followed by neurologicalsequelae such as mental retardation. Thus, it is a problem that Patients with the symptomaticcongenital cytomegalovirus infection have an impaired growth and development. Currently,
there is no approved treatment for neonates/infants with for symptomatic congenital
cytomegalovirus infection in Japan or overseas, and therefore, there is an unmet medical
need in this patient population.
Valixa® Dry Syrup obtained manufacturing and marketing approval in Japan in 2018. It isapproved as a therapeutic drug for cytomegalovirus infection in “acquired immunodeficiency
syndrome,” “organ transplantation (including hematopoietic stem cell transplantation),” and“malignant tumors,” and a suppressant for cytomegalovirus infection associated with “organtransplantation (excluding hematopoietic stem cell transplantation).” Orphan drug
designation for the treatment of symptomatic congenital cytomegalovirus infection has beengranted.
MTPC will continue to advance R&D activities so that we can deliver the new treatment
options for diseases with unmet medical needs, including rare diseases.
Contact:
Mitsubishi Chemical Group Corporation
Corporate Communications Division
Osaka Corporate Communications Department+81-6-6205-5119