Takeda’s Dengue vaccine candidate gets USFDA’s priority review | The Financial Express

Takeda’s Dengue vaccine candidate gets USFDA’s priority review

According to the pharma company, the final step in the path to approval in Europe is a Marketing Authorization decision from the EMA, which is expected in the coming months.

Takeda’s Dengue vaccine candidate gets USFDA’s priority review
Dengue is a mosquito-borne virus endemic in more than 125 countries, including the U.S. territories of Puerto Rico, the U.S. Virgin Islands and American Samoa. (File)

Takeda on Wednesday announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review of the Biologics License Application (BLA) for TAK-003, the company’s investigational dengue vaccine candidate.

In the U.S., TAK-003 is being evaluated for the prevention of dengue disease caused by any dengue virus serotype in individuals 4 years through 60 years of age.

Dengue is a mosquito-borne virus endemic in more than 125 countries, including the U.S. territories of Puerto Rico, the U.S. Virgin Islands and American Samoa. Incidence of dengue has increased globally over the past two decades and is a leading cause of fever among travelers returning from Latin America, the Caribbean and Southeast Asia.

“If approved, we believe TAK-003 has the potential to become an important dengue prevention option for healthcare providers, and we continue to be encouraged by our discussions with the FDA. This year, of the 888 dengue infections in the U.S., 96% were a result of travel to dengue endemic areas. Of the 316 dengue infections in U.S. endemic territories, 97% were locally transmitted.[iv] At Takeda, we are guided by our commitment to serving these affected populations and are fully committed to working with the FDA to advance this filing,” said Gary Dubin, M.D., president of the Global Vaccine Business Unit at Takeda in a statement.

Currently, TAK-003 has not been approved by the FDA or any other health authority outside of Indonesia. Following the approval of TAK-003 in Indonesia, Takeda will continue to progress regulatory filings in other dengue-endemic and non-endemic countries.

In October this year, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of Takeda’s dengue vaccine candidate, TAK-003, for the prevention of dengue disease caused by any serotype in individuals four years of age and older in Europe and in dengue-endemic countries participating in the parallel EU-M4all procedure.

According to the pharma company, the final step in the path to approval in Europe is a Marketing Authorization decision from the EMA, which is expected in the coming months. Regulatory reviews will also progress in dengue-endemic countries in Latin America and Asia, it stated.

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First published on: 23-11-2022 at 16:30 IST