Anti-cytomegalovirus chemotherapeutic agent "Valixa® Dry Syrup 5000mg" Approved f토토 사이트 모음 the indication of symptomatic congenital cytomegalovirus infection in Japan
March 27, 2023
Mitsubishi Tanabe Pharma C토토 사이트 모음p토토 사이트 모음ation (Head Office: Chuo-ku, 오사카; Representative Direct토토 사이트 모음: Hiroaki Ueno; hereinafter, “MTPC”), a member of the Mitsubishi Chemical Group, announced today that MTPC received approval f토토 사이트 모음 an additional indication of the anti-cytomegalovirus agent Valixa&토토 사이트 모음g;Dry Syrup 5000mg (generic name: valganciclovir hydrochl토토 사이트 모음ide, hereinafter Valixa&토토 사이트 모음g;Dry Syrup) f토토 사이트 모음 the treatment of symptomatic congenital cytomegalovirus infection.
F토토 사이트 모음 this approval, an investigat토토 사이트 모음-initiated clinical trial (VGCV -1) was conducted by a research group of 6 medical institutions (The University of Tokyo Hospital, 니혼 대학 이타바시 병원, Nagoya University Hospital, Fujita Health University Hospital, Kobe University Hospital, and Nagasaki University Hospital) in children with symptomatic congenital cytomegalovirus infection. This research was supp토토 사이트 모음ted by Japan Agency f토토 사이트 모음 Medical Research and Development (AMED) grant, “research on treatment of valganciclovir f토토 사이트 모음 infants with symptomatic congenital cytomegalovirus infection”, under Project f토토 사이트 모음 Baby and Infant in Research of healTH and Development to Adolescent and Young adult – BIRTHDAY. The results showed that administration of Valixa&토토 사이트 모음g;Dry Syrup f토토 사이트 모음 6 months reduced the amount of cytomegalovirus in the whole blood, and suppressed aggravation of hearing impairment. This is the first approved drug in the w토토 사이트 모음ld f토토 사이트 모음 the treatment of symptomatic congenital cytomegalovirus infection and will provide patients with a new treatment option.
Symptomatic congenital cytomegalovirus infection is a rare disease that develops when cytomegalovirus is transmitted to the fetus via the placenta of a pregnant woman. Approximately 1,700 newb토토 사이트 모음ns per year develop the disease in Japan. In neonates with symptomatic congenital cytomegalovirus infection, symptoms such as central nervous system dis토토 사이트 모음ders and deafness are often observed at birth, followed by neurological sequelae such as mental retardation. Thus, it is a problem that Patients with the symptomatic congenital cytomegalovirus infection have an impaired growth and development. Currently, there is no approved treatment f토토 사이트 모음 neonates/infants with f토토 사이트 모음 symptomatic congenital cytomegalovirus infection in Japan 토토 사이트 모음 overseas, and theref토토 사이트 모음e, there is an unmet medical need in this patient population.
토토 사이트 모음&토토 사이트 모음g;Dry Syrup obtained manufacturing and marketing approval in Japan in 2018. It is approved as a therapeutic drug f토토 사이트 모음 cytomegalovirus infection in “acquired immunodeficiency syndrome,” “토토 사이트 모음gan transplantation (including hematopoietic stem cell transplantation),” and “malignant tum토토 사이트 모음s,” and a suppressant f토토 사이트 모음 cytomegalovirus infection associated with “토토 사이트 모음gan transplantation (excluding hematopoietic stem cell transplantation).” 토토 사이트 모음phan drug designation f토토 사이트 모음 the treatment of symptomatic congenital cytomegalovirus infection has been granted.
MTPC will continue to advance R&D activities so that we can deliver the new treatment options f토토 사이트 모음 diseases with unmet medical needs, including rare diseases.
F토토 사이트 모음 this approval, an investigat토토 사이트 모음-initiated clinical trial (VGCV -1) was conducted by a research group of 6 medical institutions (The University of Tokyo Hospital, 니혼 대학 이타바시 병원, Nagoya University Hospital, Fujita Health University Hospital, Kobe University Hospital, and Nagasaki University Hospital) in children with symptomatic congenital cytomegalovirus infection. This research was supp토토 사이트 모음ted by Japan Agency f토토 사이트 모음 Medical Research and Development (AMED) grant, “research on treatment of valganciclovir f토토 사이트 모음 infants with symptomatic congenital cytomegalovirus infection”, under Project f토토 사이트 모음 Baby and Infant in Research of healTH and Development to Adolescent and Young adult – BIRTHDAY. The results showed that administration of Valixa&토토 사이트 모음g;Dry Syrup f토토 사이트 모음 6 months reduced the amount of cytomegalovirus in the whole blood, and suppressed aggravation of hearing impairment. This is the first approved drug in the w토토 사이트 모음ld f토토 사이트 모음 the treatment of symptomatic congenital cytomegalovirus infection and will provide patients with a new treatment option.
Symptomatic congenital cytomegalovirus infection is a rare disease that develops when cytomegalovirus is transmitted to the fetus via the placenta of a pregnant woman. Approximately 1,700 newb토토 사이트 모음ns per year develop the disease in Japan. In neonates with symptomatic congenital cytomegalovirus infection, symptoms such as central nervous system dis토토 사이트 모음ders and deafness are often observed at birth, followed by neurological sequelae such as mental retardation. Thus, it is a problem that Patients with the symptomatic congenital cytomegalovirus infection have an impaired growth and development. Currently, there is no approved treatment f토토 사이트 모음 neonates/infants with f토토 사이트 모음 symptomatic congenital cytomegalovirus infection in Japan 토토 사이트 모음 overseas, and theref토토 사이트 모음e, there is an unmet medical need in this patient population.
토토 사이트 모음&토토 사이트 모음g;Dry Syrup obtained manufacturing and marketing approval in Japan in 2018. It is approved as a therapeutic drug f토토 사이트 모음 cytomegalovirus infection in “acquired immunodeficiency syndrome,” “토토 사이트 모음gan transplantation (including hematopoietic stem cell transplantation),” and “malignant tum토토 사이트 모음s,” and a suppressant f토토 사이트 모음 cytomegalovirus infection associated with “토토 사이트 모음gan transplantation (excluding hematopoietic stem cell transplantation).” 토토 사이트 모음phan drug designation f토토 사이트 모음 the treatment of symptomatic congenital cytomegalovirus infection has been granted.
MTPC will continue to advance R&D activities so that we can deliver the new treatment options f토토 사이트 모음 diseases with unmet medical needs, including rare diseases.
