💉Takeda’s Zika Vaccine Candidate Receives U.S. FDA Fast Track Designation
Osaka, Japan – Takeda Pharmaceutical Company Limited [TSE: 4502], (“Takeda”) today 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.