Japanese pharma major Takeda pharmaceutical has said it is holding talks with India’s medicine regulator, the Drug Controller General of India (DCGI), for bringing its dengue vaccine to the country.
“We are discussing with the DCGI in terms of regulatory approval and it’s an ongoing process,” Mahender Nayak, head of Asia Pacific, Takeda Pharmaceuticals, told Moneycontrol.
Nayak, speaking exclusively to Moneycontrol on the sidelines of 20th BioAsia event, said the company was hopeful about the opportunity for the dengue vaccine in India.
“We are very optimistic for India and the opportunity is still there. We need to work collaboratively with the government and different stakeholders on this,” he added.
In December 2022, the European Commission granted Takeda marketing authorisation for its dengue vaccine Qdenga for individuals from four years of age in the European Union.
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The approval came after the European Medicines Agency’s committee for medicinal products for the first time recommended a dengue vaccine for human use in October.
The Asia-Pacific head said the company is launching the vaccine in Indonesia, adding that the market in the South Asian countries was a key focus for Takeda.
“It’s the countries in the Southeast Asian region, Latin American region and India which will be a key focus. It’s not a global R&D vaccine, it’s specifically for this part of the world,” he said.
According to the Indian drug regulator’s office, the subject expert committee (SEC) has discussed Takeda’s application for conducting trials of the tetravalent vaccine. The minutes of the SEC meeting showed that Takeda presented its proposal for grant of permission to conduct Phase 3 clinical trial of dengue tetravalent vaccine.
“The efficacy of the dengue vaccine in providing protection against dengue infection is currently being evaluated in Phase 3 trials in many countries,” the minutes said.
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The document showed that after a detailed deliberation, the committee recommended Takeda to 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.
The company has been further asked to constitute the Data and Safety Monitoring Board for monitoring the Phase 3 clinical trial at regular intervals. “The firm should submit revised protocol for further deliberation before the committee,” the document said.
When Moneycontrol reached out to Takeda for a comment on the SEC observations, the company said it is working with the panel on the recommendations for the dengue vaccine candidate.
“We are working in full cooperation with regulatory authorities to assess and make the dengue vaccine available to all who can potentially benefit from it after receipt of regulatory approvals under applicable laws,” the company statement said.
Dengue and malaria were among the top vector-borne diseases in India in 2021, government data shows. Caused by mosquito bite like malaria, dengue is characterised by high fever and causes hemorrhaging in severe cases and lead to death if left untreated.
As many as 1,089 dengue deaths have been reported in India between 2017 to 2021 November, data shows.
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