Valneva wins race, gaining FDA approval for chikungunya vaccine Ixchiq

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来源: FiercePharma

Valneva, led by CEO Thomas Lingelbach, has become the first company to win approval for a vaccine that defends against the mosquito-borne chikungunya virus.

Valneva has won the race in the U.S. to gain approval of its vaccine for the chikungunya virus and the valuable award that goes along with it.

The FDA green light—which is the world's first for the chikungunya virus—is accompanied by a priority review voucher (PRV) that can reduce the review of a drug application from six to three months. Valneva said it will sell the PRV to monetize its R&D programs.

Hours before the regulator revealed the green light on Thursday, the French company—in its quarterly earnings presentation—included a boost of between 90 million euros and 110 million euros ($96 million and $117 million) from the sale of the PRV in its 2023 revenue guidance.

Valneva beat out several companies in the race to develop a chikungunya vaccine. In August, Bavarian Nordic revealed successful results of a phase 3 trial and is set up to make its shot available in 2025. The Danish company acquired the shot, along with two other vaccines, from Emergent BioSolutions.

Valneva’s single-dose, live-attenuated shot, VLA1553, will be known commercially as Ixchiq. It is recommended for adults at increased risk of exposure to the chikungunya virus, which is carried by mosquitos in tropical areas of the world.

The accelerated approval came three months late as the FDA needed more time to hammer out its specifications for a phase 4, postmarketing confirmatory study. The endorsement was based on studies that showed 99% of recipients developed antibodies that could neutralize the virus in test tubes. Monkeys infused with the antibodies got the virus but did not develop symptoms.

In the last 15 years, 5 million have cases of chikungunya have emerged. The virus is a growing threat as it has been contracted in more than half of the world’s countries, including recent cases in Spain, Italy and France.

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

Valneva said it plans to begin commercializing Ixchiq in the U.S. early next year. The Advisory Committee on Immunization Practices will vote on how to recommend the vaccine in late February.

Chikungunya, which was first detected in Tanzania in 1952, has no known treatment and can be deadly in newborns. In adults, it causes joint pain and fever. Other symptoms can include headache, muscle pain, rash and joint swelling, with effects persisting for months or even years, the FDA said. It will likely be recommended for U.S. travelers headed to tropical areas where chikungunya is a threat.

"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," Juan Carlos Jaramillo, M.D., Valneva's chief medical officer, said. "Chikungunya has already spread to over 110 countries and is currently regarded as one of the most likely viral infections to emerge in new geographic areas."

Early this year, Merck stopped development of its chikungunya vaccine candidate, which it gained in a $366 million acquisition of Themis Bioscience in 2020. India’s Bharat Biotech also is developing a chikungunya shot.

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