(BFM Bourse) – Valneva announces that it has submitted a marketing authorization request to Health Canada for VLA1553, its vaccine candidate against chikungunya, a viral disease transmitted by certain mosquitoes.
Valneva is on all fronts to launch the world’s first anti-chikungunya vaccine. Chikungunya is a viral disease transmitted by certain mosquitoes, resulting in particular in acute fevers and joint pain.
The laboratory announced on Tuesday that it had filed with Health Canada an application for marketing authorization (MA) for its single-injection vaccine candidate against chikungunya, VLA1553, for people aged 18 and over. At the end of December 2022, Valneva submitted a similar authorization application which is undergoing a priority review with the US health authority, the Food and Drug Administration (FDA), with a target date for completing this review. set at the end of August 2023 under the Prescription Drug User Fee Act (PDUFA).
These two applications in North America follow the publication in March 2022 of positive immunogenicity and safety data for the phase III study (the last step before potential marketing) evaluating this candidate. VLA1553 vaccine. Valneva also recalls having announced conclusive results for its chikungunya vaccine candidate at the end of 2022.
The results presented by Valneva indicated that 99% of the participants maintained neutralizing antibody titers above the sero-response threshold of 150, twelve months after a single vaccination. Persistence was also similar in patients older than 65 years compared to young adults.
Results expected in Brazil
Valneva advises that a clinical study of VLA1553 in adolescents is ongoing in Brazil, to potentially enable future regulatory submissions regarding this age group if VLA1553 is approved for use in adults.
This trial, conducted by Valneva’s partner Instituto Butantan, could support licensing of the vaccine in Europe and Brazil, which would be the first potential licensing for use in an endemic population. The first results are expected in mid-2023. The company further expects to file a marketing authorization application for VLA1553 in Europe in the second half of 2023.
The company is therefore counting on its vaccine against chikungunya to revive after a complicated year 2022, due to the multiple disappointments on its vaccine against Covid-19. Valneva has experienced many difficulties in commercializing this vaccine.
Moreover, the Franco-Austrian laboratory seems to have made up its mind about the commercial failure of this vaccine. For the current year, the Valneva group expects to achieve between 130 million and 150 million euros in product sales in 2023, including marginal sales of vaccines against Covid-19 in Bahrain, the first country in the world to have authorized the Valneva product. In all, the company expects to achieve a turnover of between 220 and 260 million euros for the current financial year.
These forecasts were confirmed after a good start to 2023 for Valneva. The Franco-Austrian laboratory saw its turnover increase in one year from 21.8 million to 33.5 million euros in the first quarter of 2023. Valneva notably benefited from dynamic sales for its two vaccines, Ixiaro – against encephalitis – and Dukoral – against cholera. This good start to the year has been welcomed by the markets, Valneva has posted monthly gains of 30% since this quarterly milestone, including 0.6% on Tuesday.
Sabrina Sadgui – ©2023 BFM Bourse
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