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news.Bayer HealthCare has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for Gadovist (gadobutrol) injection for contrast-enhancement magnetic resonance imaging (MRI) in cranial, spinal, the body and extremeties at a dose of 0.1ml/kg body weight.
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Gadovist is the first high concentration/high relaxivity gadolinium-based contrast agent to be approved in Japan.
In Japan, there are more than 1.6 million MRI procedures conducted each year which are contrast-enhanced.
Bayer HealthCare Medical Care division chief medical officer and head of Innovation Dr Christiane Pering said: "The approval of Gadovist in Japan provides local radiologists with access to the first high concentration/high relaxivity gadolinium-based contrast agent.
"Gadovist has demonstrated efficacy in providing the potential of high quality images of the central nervous system and whole body for patients supporting effective diagnosis and disease management by their healthcare teams and ultimately enabling good patient care."
The approval is based on data from two key clinical studies involving patients from Japan.
The first study was a 223-patient Phase III open label trial in Japan which showed superiority of gadobutrol-enhanced MRI of the central nervous system (CNS) compared to unenhanced MRI.
The second was a 363-patient Pan-Asian Phase III trial with 120 Japanese patients, which showed non-inferiority of gadobutrol-enhanced MR images of the body (breast, heart, abdomen, kidney, pelvis and extremity) to those obtained through the use of gadopentetate dimeglumine.