The U.S. Food and Drug Administration has granted ‘fast track’ status to Takeda Pharmaceutical's purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate.
The drug (TAK-426) is in early development stages, with 240 patients between the ages of 18 and 49 being tested.
The FDA’s ‘fast track’ designation aims to facilitate the development and expedite the review process for certain drugs and vaccines for serious conditions with unmet medical need.
The 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.
Read the Business Wire release