Valneva’s chikungunya vaccine Ixchiq scores European nod

2024-07-01

临床3期上市批准临床结果疫苗

Valneva on Monday said the European Commission approved its live-attenuated vaccine Ixchiq to prevent disease from exposure to the chikungunya virus in adults aged 18 years and older. This marks the third regulatory approval for the world’s first chikungunya vaccine, after being cleared in the US last year and recently in Canada.

“Climate change has caused the Aedes mosquito…to spread to areas in Europe that were previously unaffected,” explained Juan Carlos Jaramillo, chief medical officer of Valneva. “It is critical to provide a vaccine solution not only to European travellers going to endemic chikungunya areas…but also to the local European populations,” he added, with the product expected to hit European markets in the fourth quarter.

The approval follows the European Medicines Agency (EMA) drug advisory panel’s favourable opinion last month and is backed by findings from the Phase III VLA1553-301 study of over 4000 adults in the US. The trial demonstrated a 98.9% seroresponse rate at 28 days following a single dose of Ixchiq, with nearly 97% of participants sustaining the response for 24 months. The durability was consistent across younger and older adults. Furthermore, the company reported additional pivotal data six months after a single dose in adolescents, supporting a potential label expansion for use in ages 12 to 17.

The accelerated FDA approval, which was originally expected in August last year, was pushed to November after the agency sought more time to align and agree on the vaccine’s Phase IV programme. The FDA also required the company to include a warning about potential risks of severe chikungunya-like adverse reactions in the vaccine’s label.

Valneva also intends to use the clinical data to support an ongoing regulatory review of Ixchiq in Brazil, making it the first potential approval for use in an endemic population. It has partnered with the Coalition for Epidemic Preparedness Innovations (CEPI) and Instituto Butantan in Brazil to improve access to the vaccine in low- and middle-income countries.

Besides Valneva, Danish biotech Bavarian Nordic is eyeing the chikungunya vaccine space, having recently submitted marketing applications to the FDA and EMA for its virus-like particle-based candidate.

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