Takeda gets USFDA's priority review of BLA for its dengue vaccine candidate
New Delhi, Nov 23 (PTI) Japanese pharma firm Takeda on Wednesday said the US health regulator has accepted and granted priority review of the Biologics License Application (BLA) for 'TAK-003', its investigational dengue vaccine candidate.
Currently, TAK-003 has not been approved by the US Food and Drug Administration (USFDA) or any other health authority outside of Indonesia, the company said in a statement.
The vaccine candidate is being evaluated for the prevention of dengue disease caused by any dengue virus serotype in individuals 4 years through 60 years of age, it added.
"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 (US)FDA," Takeda President Global Vaccine Business Unit Gary Dubin said.
Dengue is in more than 125 countries, including the US territories of Puerto Rico, the US Virgin Islands and American Samoa, Takeda said, adding, incidence of the mosquito borne disease has increased globally over the past two decades and is a leading cause of fever among travellers returning from Latin America, the Caribbean and Southeast Asia.
Takeda said following the approval of TAK-003 in Indonesia, it will continue to progress regulatory filings in other dengue-endemic and non-endemic countries.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had in October 2022, recommended the approval of TAK-003 for the prevention of dengue disease in individuals four years of age and older in Europe and in dengue-endemic countries participating in the parallel EU-M4all (EU-Medicines for all) procedure.
The final step in the path to the approval in Europe is a marketing authorisation decision from the EMA, which is expected in the coming months, it added.
"Regulatory reviews will also progress in dengue-endemic countries in Latin America and Asia," the statement said. PTI RKL SHW SHW