U.S FDA grants Fast Track designation to Takeda’s TAK-426

Takeda Pharmaceutical company Limited asserted that the U.S Food and Drug Administration has extended Fast Track designation to TAK-426 i.e Takeda’s Zika virus vaccine candidate. TAK-426 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. 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.

The FDA’s Fast Track designation is a process implied to facilitate the development and expedite the review of drugs and vaccines for serious conditions and fails to cater to medical requirements. 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 Virs has 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.

Laurence De Moerlooze, PhD, Global Zika Program Lead said “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.”