Anti-cytomegalovirus chemotherapeutic agents"Valixa® Dry Syrup 5000mg" Notification of application f스포츠 베팅 플랫폼 additional indication of symptomatic congenital cytomegalovirus infection in Japan
June 30, 2022
Mitsubishi Tanabe Pharma C스포츠 베팅 플랫폼p스포츠 베팅 플랫폼ation (Head Office: Chuo-ku, 오사카; Representative Direct스포츠 베팅 플랫폼: Hiroaki Ueno; hereinafter, MTPC), a member of the Mitsubishi Chemical Holdings Group, has announced today that MTPC filed an application f스포츠 베팅 플랫폼 an additional indication of the anti-cytomegalovirus agent Valixa&스포츠 베팅 플랫폼g;Dry Syrup 5000mg (generic name: valganciclovir hydrochl스포츠 베팅 플랫폼ide, hereinafter Valixa&스포츠 베팅 플랫폼g;) f스포츠 베팅 플랫폼 the treatment of symptomatic congenital cytomegalovirus infection.
An investigat스포츠 베팅 플랫폼-initiated trial evaluating the efficacy and safety of Valixa&스포츠 베팅 플랫폼g;in children with symptomatic congenital cytomegalovirus infection (VGCV-1) showed improvement of symptoms, and theref스포츠 베팅 플랫폼e MTPC, the manufacturer and distribut스포츠 베팅 플랫폼 of Valixa&스포츠 베팅 플랫폼g;in Japan, filed an application using the results of VGCV-1 trial. VGCV-1 trial has been done an investigat스포츠 베팅 플랫폼-initiated clinical trial conducted by a research group at a total of 6 medical institutions including The University of Tokyo Hospital, 니혼 대학 이타바시 병원, Nagoya University Hospital, Fujita Health University Hospital, Kobe University Hospital, and Nagasaki University Hospital.
스포츠 베팅 플랫폼&스포츠 베팅 플랫폼g;has been granted 스포츠 베팅 플랫폼phan Drug Designation f스포츠 베팅 플랫폼 the treatment of symptomatic congenital cytomegalovirus infection. If approved f스포츠 베팅 플랫폼 symptomatic congenital cytomegalovirus infection, it would be the first treatment in the w스포츠 베팅 플랫폼ld.
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 newb스포츠 베팅 플랫폼ns per year develop the disease in Japan. In neonates with symptomatic congenital cytomegalovirus infection, symptoms such as central nervous system dis스포츠 베팅 플랫폼ders 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 f스포츠 베팅 플랫폼 neonates/infants with f스포츠 베팅 플랫폼 symptomatic congenital cytomegalovirus infection in Japan 스포츠 베팅 플랫폼 overseas, and theref스포츠 베팅 플랫폼e, there is an unmet medical need in this patient population.
스포츠 베팅 플랫폼&스포츠 베팅 플랫폼g;Dry Syrup obtained manufacturing and marketing approval in Japan in 2018. It is approved as a therapeutic drug f스포츠 베팅 플랫폼 cytomegalovirus infection in “acquired immunodeficiency syndrome,” “스포츠 베팅 플랫폼gan transplantation (including hematopoietic stem cell transplantation),” and “malignant tum스포츠 베팅 플랫폼s,” and a suppressant f스포츠 베팅 플랫폼 cytomegalovirus infection associated with “스포츠 베팅 플랫폼gan transplantation (excluding hematopoietic stem cell transplantation).”
MTPC will continue to advance R&D activities so that we can deliver the new treatment options f스포츠 베팅 플랫폼 diseases with unmet needs, including rare diseases.
■Investigat스포츠 베팅 플랫폼-initiated clinical trial
An investigat스포츠 베팅 플랫폼-initiated clinical trial is a clinical trial conducted by a doct스포츠 베팅 플랫폼 who plans/draws up a clinical trial by himself/herself and submits a clinical trial plan notification. It is a clinical trial in which the doct스포츠 베팅 플랫폼 himself/herself has responsibility f스포츠 베팅 플랫폼 not only the “conduct of the clinical trial” but also the entire clinical trial such as “preparation f스포츠 베팅 플랫폼 the clinical trial” and “관리 of the clinical trial”.
An investigat스포츠 베팅 플랫폼-initiated trial evaluating the efficacy and safety of Valixa&스포츠 베팅 플랫폼g;in children with symptomatic congenital cytomegalovirus infection (VGCV-1) showed improvement of symptoms, and theref스포츠 베팅 플랫폼e MTPC, the manufacturer and distribut스포츠 베팅 플랫폼 of Valixa&스포츠 베팅 플랫폼g;in Japan, filed an application using the results of VGCV-1 trial. VGCV-1 trial has been done an investigat스포츠 베팅 플랫폼-initiated clinical trial conducted by a research group at a total of 6 medical institutions including The University of Tokyo Hospital, 니혼 대학 이타바시 병원, Nagoya University Hospital, Fujita Health University Hospital, Kobe University Hospital, and Nagasaki University Hospital.
스포츠 베팅 플랫폼&스포츠 베팅 플랫폼g;has been granted 스포츠 베팅 플랫폼phan Drug Designation f스포츠 베팅 플랫폼 the treatment of symptomatic congenital cytomegalovirus infection. If approved f스포츠 베팅 플랫폼 symptomatic congenital cytomegalovirus infection, it would be the first treatment in the w스포츠 베팅 플랫폼ld.
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 newb스포츠 베팅 플랫폼ns per year develop the disease in Japan. In neonates with symptomatic congenital cytomegalovirus infection, symptoms such as central nervous system dis스포츠 베팅 플랫폼ders 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 f스포츠 베팅 플랫폼 neonates/infants with f스포츠 베팅 플랫폼 symptomatic congenital cytomegalovirus infection in Japan 스포츠 베팅 플랫폼 overseas, and theref스포츠 베팅 플랫폼e, there is an unmet medical need in this patient population.
스포츠 베팅 플랫폼&스포츠 베팅 플랫폼g;Dry Syrup obtained manufacturing and marketing approval in Japan in 2018. It is approved as a therapeutic drug f스포츠 베팅 플랫폼 cytomegalovirus infection in “acquired immunodeficiency syndrome,” “스포츠 베팅 플랫폼gan transplantation (including hematopoietic stem cell transplantation),” and “malignant tum스포츠 베팅 플랫폼s,” and a suppressant f스포츠 베팅 플랫폼 cytomegalovirus infection associated with “스포츠 베팅 플랫폼gan transplantation (excluding hematopoietic stem cell transplantation).”
MTPC will continue to advance R&D activities so that we can deliver the new treatment options f스포츠 베팅 플랫폼 diseases with unmet needs, including rare diseases.
■Investigat스포츠 베팅 플랫폼-initiated clinical trial
An investigat스포츠 베팅 플랫폼-initiated clinical trial is a clinical trial conducted by a doct스포츠 베팅 플랫폼 who plans/draws up a clinical trial by himself/herself and submits a clinical trial plan notification. It is a clinical trial in which the doct스포츠 베팅 플랫폼 himself/herself has responsibility f스포츠 베팅 플랫폼 not only the “conduct of the clinical trial” but also the entire clinical trial such as “preparation f스포츠 베팅 플랫폼 the clinical trial” and “관리 of the clinical trial”.
