evelopment of many chronic diseases and we are pleased that Takeda has obtained manufacturing and marketing approval by the regulatory authorities in Japan.”
“Obesity is an increasingly important issue in Japan with limited treatment options,” said Nancy Joseph-Ridge M.D., General Manager of Takeda’s Pharmaceutical Development Division. “The approval of OBLEAN, with its novel mechanism of action, provides options for this unmet medical need to patients with obesity, with complications of both type 2 diabetes and dyslipidemia in Japan.”
* A type of PMDA consultation that is conducted at the development stage before NDA submission based on the available quality, non-clinical and clinical data and that is primarily intended to identify the issues anticipated during the NDA review as much as possible.
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