Japanese multinational pharmaceutical company, with American and British roots, Takeda, is holding talks with India’s medicine regulator, the Drug Controller General of India (DCGI), for bringing its dengue vaccine to the country.
Mahender Nayak, head of Asia Pacific, Takeda Pharmaceuticals, said that the company was discussing terms of regulatory approval with DCGI, “and it’s an ongoing process.”
According to the Indian drug regulator’s office, the Subject Expert Committee (SEC) has discussed Takeda’s proposal for permission to conduct Phase 3 clinical trial of its dengue tetravalent vaccine.
After a detailed deliberation, the Committee recommended
Takeda revise the Phase 3 clinical trial protocol for the Indian population. The SEC also asked Takeda to include efficacy as an objective of Phase 3 clinical trial and revise the sample size accordingly.
Takeda was further advised to set up a Data and Safety Monitoring Board for monitoring the Phase 3 clinical trial at regular intervals.
