The US Food and Drug Administration (FDA) has approved Ixchiq, Valneva’s single-dose, live-attenuated vaccine for the prevention of disease caused by chikungunya virus (CHIKV).
The vaccine is indicated in individuals 18 years of age and older who are at increased risk of exposure to CHIKV.
Ixchiq was granted Fast Track and Breakthrough Therapy designations and the application was granted Priority Review. It was approved under accelerated approval based on anti-CHIKV neutralising antibody titers and is contingent upon verification of clinical benefit in confirmatory studies.
“Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions,” said Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research. “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.”
The safety of Ixchiq was evaluated in two clinical studies conducted in North America in which about 3,500 participants 18 years of age and older received a dose of the vaccine.
Valneva reported final pivotal Phase III data for the vaccine in March 2022 showing a 98.9% seroresponse rate at 28 days with a single vaccination and final lot-to-lot consistency results in May 2022. Ixchiq-induced seroresponse was sustained over time with a 96.3% seroresponse rate six months post-vaccination.
The company will continue to evaluate antibody persistence for at least five years.
The chikungunya virus is primarily transmitted to people through the bite of an infected mosquito. Chikungunya is designated an emerging global health threat with at least five million cases of chikungunya virus infection reported during the past 15 years. The highest risk of infection is in tropical and subtropical regions of Africa, Southeast Asia, and parts of the Americas where chikungunya virus-carrying mosquitos are endemic. However, chikungunya virus has spread to new geographical areas causing a rise in global prevalence of the disease.
The most common symptoms of chikungunya include fever and joint pain. Other symptoms may include a rash, headache, and muscle pain. Some individuals may experience debilitating joint pain that persists for months or even years. Treatment includes rest, fluids, and over-the-counter medications for pain and fever.