Takeda's NDA for cell cultured influenza vaccine approved in Japan
The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Takeda Pharmaceutical's new drug application (NDA) of Cell Cultured Influenza vaccine H5N1 'TAKEDA' 1mL (Cell Cultured Influenza vaccine (H5N1Strain)) and Cell Cultured Influenza vaccine (Prototype) 'TAKEDA' 1mL (Cell Cultured Influenza vaccine (Prototype)) for prevention of pandemic influenza.
The new vaccine will be manufactured at a newly-established facility at the company's Hikari Plant in Hikari City, Yamaguchi Prefecture.
In 2010, Takeda and Baxter International have entered into a development, license and technology transfer agreement under which Baxter licensed exclusive rights to its proprietary cell culture-based pandemic influenza vaccine technology for the Japanese market.
As part of that deal, Takeda has been carrying out pandemic influenza vaccine development activities jointly with Baxter.
The company has submitted the NDA to MHLW in March 2013 and the approval means that Takeda is now able to manufacture and supply pandemic influenza vaccines in Japan using new manufacturing technologies licensed from Baxter.
Takeda head of Vaccine Business Division Rajeev Venkayya said the approval by the MHLW represents an important milestone in the company's collective efforts to strengthen pandemic preparedness in Japan.
"Takeda remains committed to advancing public health in Japan and across the globe," Venkayya said.
Image: Takeda Midosuji Building, the head office of Takeda Pharmaceutical Company, in Chuo-ku, Osaka, Japan. Photo: courtesy of J o