Takeda has picked up picked up Fast Track designation in the US for TAK-426, its whole Zika virus vaccine candidate.
The Food and Drug Administration’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 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. It has spread in recent years to more than 84 countries, territories or subnational areas, including the US.
There is currently no vaccine or medicine for Zika.
Takeda’s Zika vaccine candidate is currently being studied in a Phase 1 trial (ZIK-101) under a US Investigational New Drug application. If initial data from ZIK-101 are supportive, Takeda will work to progress into Phase 2 development as soon as possible.