Therapy Areas: Cardiovascular
US FDA Grants Fast Track Designation to Takeda for Zika Vaccine Candidate
30 January 2018 - - The US Food and Drug Administration has granted fast track designation to Osaka, Japan-based R and D-driven pharmaceutical company Takeda Pharmaceutical Company Ltd. (TSX: 4502) for TAK-426, its purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate, the company said.
Takeda's TAK-426 Zika vaccine candidate is currently being studied in a Phase 1 trial, ZIK-101, a randomized, placebo-controlled, double-blind trial designed to evaluate safety and immunogenicity in 240 male and female subjects between the ages of 18 and 49.7 under a US investigational new drug application.
The Phase 1 trial is designed to assess several dose levels of the vaccine candidate to support the progression of TAK-426 into future studies.
Beyond Zika, Takeda is pursuing several vaccine programs to address high-priority infectious diseases, including dengue, norovirus and polio.
Takeda is a research-based global company with its main focus on pharmaceuticals. The company has a commercial presence covering around 70 countries, with particular strength in Asia, North America, Europe, and fast-growing emerging markets including Latin America, Russia-CIS and China. Areas of R and D focus include central nervous system, cardiovascular and metabolic, gastroenterology, oncology, and vaccines.
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