USA — The FDA has granted approval to Valneva’s chikungunya vaccine, Ixchiq, making it the first-ever vaccine to secure regulatory clearance for combatting the virus.

This endorsement, aimed at individuals aged 18 and above with an elevated risk of exposure to the mosquito-borne chikungunya virus, is accompanied by a noteworthy priority review voucher (PRV), capable of halving the drug application review period from six to three months.

Valneva, strategically capitalizing on this achievement, plans to monetize its R&D programs by selling the PRV.

This financial maneuver was unveiled in the French company’s quarterly earnings presentation, projecting a revenue boost ranging from 90 million to 110 million euros (US$96 million and US$117 million) in 2023.

The anticipation of this revenue injection underscores the significant impact of the FDA’s green light on Valneva’s financial outlook.

The company’s triumph in the race to develop a chikungunya vaccine is highlighted by its single-dose, live-attenuated shot, VLA1553, commercially branded as Ixchiq.

Valneva has also applied for marketing approval for Ixchiq in Canada and Europe. The chikungunya vaccine is forecasted to generate US$344 million in global sales in 2029, as per GlobalData analysis.

Positioned for adults facing an increased risk of chikungunya exposure in tropical areas, the accelerated FDA approval was three months delayed due to the regulatory body’s meticulous phase 4 specifications for a postmarketing confirmatory study.

Valneva’s success resonates against the backdrop of a competitive landscape, with Bavarian Nordic’s phase 3 trial results announced in August, projecting availability in 2025.

Valneva’s proactive approach, evidenced by the swift commercialization plans for Ixchiq in the U.S. early next year, positions it as a frontrunner in addressing the escalating threat of chikungunya.

The urgency surrounding chikungunya is emphasized by the virus’s global reach, with over 5 million cases reported in the last 15 years across more than half of the world’s countries, including recent occurrences in Spain, Italy, and France.

Recognizing the severity of the disease, Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, stressed its impact on older adults and those with underlying medical conditions.

Valneva’s Chief Medical Officer, Juan Carlos Jaramillo, M.D., underscored the urgency of the situation, stating, “It is estimated that more than 75% of the world’s population lives in areas at risk of chikungunya transmission due to factors such as global warming and climate change.”

As the Advisory Committee on Immunization Practices prepares to vote on vaccine recommendations in late February, Valneva’s Ixchiq emerges as a pivotal tool in the global battle against chikungunya.

Chikungunya, first detected in Tanzania in 1952, lacks a known treatment and can be fatal in newborns. In adults, it manifests as joint pain and fever, with lingering symptoms persisting for months or even years.

Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, emphasized the severity of chikungunya infections, stating, “Infection with the chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions.”

With no known treatment and potentially fatal consequences, the urgency to address this viral threat is paramount, especially for travelers heading to tropical regions where chikungunya poses a significant risk.

However, the chikungunya vaccine landscape has seen setbacks, with Merck discontinuing its candidate earlier this year and Bharat Biotech continuing its development efforts.

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