Takeda’s Zika Vaccine Candidate Receives U.S. FDA Fast Track Designation

Takeda Pharmaceutical Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to TAK-426, Takeda’s purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate.

The FDA’s Fast Track designation is a process designed to facilitate the development and expedite the review of drugs and vaccines for serious conditions and that fill an unmet medical need. The Fast Track process allows more frequent interactions with the FDA, rolling reviews of the Biologic License Application (BLA), and eligibility for a priority review if relevant criteria are met.

Zika can cause congenital Zika syndrome (CZS), including microcephaly and other congenital brain abnormalities, in infants born to mothers infected during pregnancy. The virus has also been associated with neurological complications, including Guillain-Barre Syndrome (GBS), in the general population. The Zika virus has spread in recent years to more than 84 countries, territories or subnational areas, including the U.S. There is currently no vaccine or medicine for Zika.

“We recognize the public health threat posed by the Zika virus,” said Laurence De Moerlooze, PhD, Global Zika Program Lead. “As soon as Takeda received funding from BARDA, we mobilized a team and prioritized development of this vaccine candidate, initiating a Phase 1 trial within 15 months of contract signature. With Fast Track designation, the ongoing support of BARDA, and the abilities of our organization, we are confident that we will continue to make expedient progress. We look forward to continuing to work closely with the FDA and BARDA, as well as other health authorities across the world, on the development of this important vaccine candidate.”

Takeda’s Zika vaccine candidate is currently being studied in a Phase 1 trial (ZIK-101) under a U.S. Investigational New Drug (IND) application. If initial data from ZIK-101 are supportive, Takeda will work to progress into Phase 2 development as soon as possible.

Beyond Zika, Takeda is pursuing several vaccine programs to address high-priority infectious diseases, including dengue, norovirus and polio. Takeda’s dengue vaccine candidate, TAK-003, was also granted Fast Track designation and is currently being evaluated in a pivotal Phase 3 efficacy study, with initial data expected this year.

This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600015C.