Takeda Receives NDA Approval For Influenza Vaccine

Developed using cell culture-based technology, Takeda’s H5N1 vaccine could help to strengthen Japan’s pandemic preparedness.

AsianScientist (Apr. 8, 2014) – Takeda Pharmaceutical Company Limited has received New Drug Application (NDA) approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for their H5N1 influenza vaccine.

In 2010, Takeda and Baxter International Inc. entered into a development, license and technology transfer agreement in which Baxter licensed exclusive rights to its proprietary cell culture-based pandemic influenza vaccine technology for the Japanese market. Under this agreement, Takeda has been conducting pandemic influenza vaccine development activities jointly with Baxter.

The vaccine will be manufactured at a newly-established facility for cell culture-based influenza vaccines at Takeda’s Hikari plant, which was partially funded by a subsidy from the Japanese government.

The NDA approval means that Takeda is now able to manufacture and supply pandemic influenza vaccines in Japan using manufacturing technologies licensed from Baxter.

“Today’s decision by the MHLW represents an important milestone in our collective efforts to strengthen pandemic preparedness in Japan,” said Dr. Rajeev Venkayya, Head of Takeda’s Vaccine Business Division. “Takeda remains committed to advancing public health in Japan and across the globe.”


Source: Takeda; Photo: AJC1/Flickr/CC.

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