The pharma company takeda strives to make its dengue vaccine available to those who can benefit from it after receipt of regulatory approvals under applicable laws in India.
Takeda Pharmaceuticals, a Japanese pharmaceutical company, is in talks with India’s Drug Controller General (DCGI) for the approval of its dengue vaccine. The company’s head of Asia Pacific, Mahender Nayak, spoke exclusively to media sources on the sidelines of the 20th BioAsia event, saying that the discussions were ongoing, and the company was hopeful about the opportunity for its dengue vaccine in India.
Takeda Pharmaceuticals has already received marketing authorisation for its dengue vaccine Qdenga in the European Union. The approval followed the European Medicines Agency’s committee for medicinal products’ recommendation in October 2022 for the vaccine’s human use. According to Nayak, the company is launching the vaccine in Indonesia and focusing on South Asian countries like India.
The Indian drug regulator’s office revealed that Takeda presented its proposal for the grant of permission to conduct a Phase 3 clinical trial of the dengue tetravalent vaccine. The SEC discussed Takeda’s application and recommended that the company revise the Phase 3 clinical trial protocol for the Indian population. The SEC also requested Takeda to include efficacy as an objective of the trial and revise the sample size accordingly.
Takeda Pharmaceuticals said in a statement that it was working with the panel on the recommendations for its dengue vaccine candidate. The company added that it was 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.
Nayak expressed optimism about the dengue vaccine’s opportunity in India and said that the company needed to work collaboratively with the government and different stakeholders to bring the vaccine to the country. He highlighted that the market in South Asian countries was a key focus for Takeda, and the vaccine was specifically designed for the Southeast Asian and Latin American regions.
Dengue is a viral infection spread by mosquitoes that can cause severe flu-like symptoms, and in severe cases, it can lead to life-threatening conditions. India has been grappling with dengue outbreaks for years, with the World Health Organization estimating over 100,000 dengue cases annually in the country.
Takeda’s dengue vaccine is considered a significant development in the fight against dengue. The vaccine is a tetravalent vaccine, which means it can protect against all four types of the virus that cause dengue. The vaccine is also considered safe, with clinical trials demonstrating a strong safety profile.
If approved, Takeda’s dengue vaccine will be a significant breakthrough in India’s fight against dengue. With the high prevalence of the disease, an effective vaccine will go a long way in reducing the number of cases and associated mortality rates. The ongoing talks between Takeda Pharmaceuticals and India’s drug regulator are an indication of the company’s commitment to making its dengue vaccine available to the Indian population.