Research & Development
Valneva Austria GmbH receives USFDA approval for Ixchiq
10 November 2023 -

Valneva Austria GmbH, a specialty vaccine company, announced on Thursday that it has received approval for Ixchiq, the first chikungunya vaccine, from the US Food and Drug Administration.

The product is approved for treatment of over 18s who are at increased risk of exposure to chikungunya virus. It is administered as a single dose by injection into the muscle. It includes a live, weakened version of the chikungunya virus and is likely to cause symptoms in the vaccine recipient similar to those experienced by people who have chikungunya disease.

The safety of the product was assessed in two clinical studies carried out in North America, in which approximately 3,500 adult participants received a dose of the vaccine, with one study including around 1,000 participants who received a placebo.

Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, said, 'Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions. Today's approval addresses an unmet medical need and is an important advancement in the prevention of a potentially debilitating disease with limited treatment options.'