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Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation  jcm9144@gmail.com

SPECIAL REPORT

US FDA approves Valneva’s IXCHIQ, the world first chikungunya vaccine.

On November 10, Valvena, a franco-austrian speciality vaccine company, based in Saint-Herblain (near Nantes in France), announced that the US FDA has approved IXCHIQ, a single-dose, live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV.  This indication was approved under accelerated approval, based on anti-CHIKV neutralising antibody titers and does request additional clinical confirmatory studies.

IXCHIQ is the first chinkungunya vaccine approved in the world. Additional regulatory dossiers have been filed in Canada and with the European Medicines Agency (EMA) in Europe.

"With this US approval, IXCHIQ becomes the world's first licensed chikungunya vaccine to address this unmet medical need, and the third vaccine that Valneva has advanced from early R&D stages to market launch” said an official at Valneva.

The chikungunya virus is transmitted to humans by infected tiger mosquitoes. It causes high fever and severe joint pain. In 43% of cases, the disease can be chronic. Symptoms can therefore last for months or even years, although death is rare. According to the World Health Organization (WHO), the chikungunya virus has spread to over 110 countries, and the Pan American Health Organization (PAHO) issued an epidemiological alert in February 2023, as the number of cases and deaths due to chikungunya continues to rise on the American continent. Moreover, with global warming, the tiger mosquito is spreading to new countries, particularly in Europe. There have been recent cases of chikungunya in France, Italy as well as in Florida.

"As a vaccine company, we are focused on providing vaccines to meet unmet medical needs, in line with our vision of contributing to a world in which no one dies or suffers from a vaccine-preventable disease. In this respect, today's authorization marks an important milestone in the prevention of chikungunya. I would like to personally thank all those who have contributed to making this possible. I'd also like to thank CEPI and the Butantan Institute for their collaboration, which could make this product available to low-and middle-income countries." said Thomas Lingelbach, Chief Executive Officer of Valneva.

The vaccine wil be available on the US market in Q1 2024.

Valneva stock increased by 8% upon the announcement of IXCHIQ approval and is now valued at € 883 millions making it the largest French biotechnology company in terms of market capitalisation. To the best of your knowledge IXCHIQ is the first major product issued from a French biotechnology company which received US FDA approval.

Valneva will hold an analyst call and a webcast at 3pm GMT on November 13, 2023.  Thomas Lingelbach Valneva’s CEO and Peter Bühler, its CFO, will host a fireside chat at 2:30 pm GMT on November 14, 2023, during the Jefferies London Healthcare Conference (November 14-16) in London to discuss Valneva’s commercial business and pipeline on infectious disease vaccines. Valneva has already partenered VLA15, its Lyme vaccine candidate, with Pfizer.

Paris, November 11, 2023

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