Vaccine company Valneva SE (Nasdaq:VALN) (Euronext Paris:VLA) announced on Wednesday that it has received marketing authorisation from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for IXCHIQ, the first chikungunya vaccine.
The single-dose vaccine -- produced at Valneva's facility in Livingston, Scotland -- is approved for individuals aged 18 and older.
The MHRA's approval was based on IXCHIQ's final pivotal Phase 3 data, demonstrating that IXCHIQ induced a rapid and strong immune response in over 4,000 participants. Studies indicate the immune response lasts at least three years across age groups.
This marks Valneva's fourth regulatory approval for IXCHIQ, following authorisations in the United States, Europe and Canada. A decision in Brazil is expected in the first quarter of 2025, which would represent the first approval in an endemic region. Valneva is also pursuing label extensions for adolescent use in multiple markets, including the UK.
Chikungunya virus, transmitted by Aedes mosquitoes, causes fever, severe joint pain and other debilitating symptoms. The World Health Organisation recognises it as a major public health concern due to its growing global impact.
Everest Medicines' EVM14 IND application receives US FDA approval
Clover Biopharmaceuticals' SCB-1019 IND application receives US FDA approval
Centivax partners with Emery Pharma on universal flu vaccine
Avance Biosciences registers with CLIA program
GSK receives approval from US FDA for Penmenvy 5-in-1 meningitis vaccine
hVIVO secures GBP2m contract for final stage of hMPV characterisation study
EU approves CSL and Arcturus Therapeutics' self-amplifying mRNA COVID-19 vaccine
Sanofi and J&J discontinue phase 3 study of E. coli vaccine candidate
Bain Capital to acquire Mitsubishi Tanabe Pharma in USD3.3bn deal
Valneva secures UK approval for world's first chikungunya vaccine
Anivive Lifesciences receives USD20m in funding from Leonid Capital Partners
ImmunityBio's ANKTIVA receives EMA review for BCG-unresponsive bladder cancer treatment
hVIVO signs LOI for landmark Phase 3 whooping cough vaccine trial with ILiAD Biotechnologies
Abyssinia Biosciences signs collaborative agreement with Cordance Medical