塩酸バンコマイシン注射用製剤の開発
2019 年 54 巻 2 号 p. 89-93
詳細
2019 年 54 巻 2 号 p. 89-93
In the late 1980s to early 1990s in Japan, when third-generation cephalosporin antibiotics were frequently used, serious nosocomial infections caused by methicillin-resistant S. aureus (MRSA) came to occur at many large-scale hospitals. The lawsuits of the medical institutions regarding deaths due to MRSA nosocomial infection, such as sepsis and pneumonia, were widely reported in the media. One of the reasons for the MRSA outbreaks was that effective antibiotics against MRSA had not yet been approved in Japan. In September 1989, an officer of the Ministry of Health and Welfare (MHW) urgently requested Shionogi to submit data and documents regarding Vancomycin Hydrochloride injection as a new drug application for MRSA treatment antibiotics. Shionogi promptly discussed this with Eli Lilly, gathered clinical and non-clinical data and documents, and applied for Vancomycin Hydrochloride injection approval to the MHW in December 1990. It was finally approved in October 1991. Vancomycin Hydrochloride injection has contributed to improving MRSA infectious treatment and drastically decreased the numbers of death by these infections in Japan, and subsequently media reports subsided. This article describes the development history of MRSA treatment antibiotics （Vancomycin Hydrochloride injection）in Japan, including specific communications with MHW, Eli Lilly and clinical expert doctors.
