Tuesday, January 30, 2018
Takeda Pharmaceutical Company Limited, today announced that the US Food and Drug Administration (FDA) has granted Fast-track designation for TAK-426, Takeda's purified, inactivated, aluminum adjuvant vaccine against Zika virus.
The FDA's Fast Track designation is a process designed to simplify the development and expedite the evaluation of drugs and vaccines for severe conditions that address an unmet medical need. The expedited process results in more frequent interactions with the FDA, ongoing reviews of Biological License Applications (BLAs), and eligibility for priority assessment if the relevant criteria are met.
Zika can cause Congenital Zika Syndrome (ZZS), including microcephaly and other congenital brain malformations, in infants born to mothers who contracted the virus during pregnancy. 1 The virus has also been associated with neurological complications, including Guillain-Barre syndrome (GBS), in the general population. In recent years, the Zika virus has spread to more than 84 countries, territories or regions, including the United States. 2 There is currently no vaccine or drug for Zika. 3
"We recognize the public health threat posed by the Zika virus," says Laurence De Moerlooze, PhD, International Program Manager for Zika. "As soon as Takeda received funding from BARDA, we mobilized a team and prioritized the development of this candidate vaccine, with the launch of the Phase 1 trial within 15 months of signing the contract. With the accelerated procedure designation, continued support from BARDA, and the capabilities of our company, we are confident that we will continue to make rapid progress, and we look forward to continuing our close collaboration with the FDA and BARDA. , as well as with other health authorities around the world,
Takeda's Zika vaccine candidate vaccine is currently being evaluated in a Phase I trial (ZIK-101) with an application for registration of a new investigational drug (IND) in the United States. If the initial data from the ZIK-101 trial is positive, Takeda will move to Phase 2 as soon as possible.
In addition to the Zika virus, Takeda is running a number of vaccine programs to fight high-priority infectious diseases, including dengue, norovirus and polio. Takeda's candidate vaccine for dengue fever, TAK-003, has also received the accelerated procedure designation and is currently being evaluated as part of a pivotal Phase 3 efficacy study , whose Initials are expected in the course of the year.
Recognition of Federal Funding
This project was funded in whole or in part by federal funding from the Department of Health and Social Services; the Office of the Assistant Secretary for Preparation and Response; of the Agency for Advanced Biomedical R & D (BARDA), under Contract No. HHSO100201600015C.
