Vaccine company Valneva SE (Nasdaq:VALN) (Euronext Paris:VLA) reported on Monday that the European Medicines Agency (EMA) has accepted the Marketing Authorisation Application (MAA) for its single-shot chikungunya vaccine candidate VLA1553.
The MAA has been granted accelerated assessment by EMA's Committee for Medicinal Products for Human Use (CHMP) due to the vaccine's potentially significant public health impact and therapeutic innovation. This designation shortens the review period from 210 to 150 days, excluding clock stops for additional information, which is standard in such procedures.
Recently approved by the US Food and Drug Administration (FDA) as IXCHIQ for individuals aged 18 and older at risk of chikungunya virus exposure, VLA1553 is indicated for the prevention of disease caused by the chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure. Valneva reported positive Phase 3 immunogenicity data in adolescents in mid-November, intended to support label extension in this age group. The trial is also crucial for potential licensing in Brazil, which would be the first potential approval for use in endemic populations.
Chikungunya, a mosquito-borne viral disease transmitted by Aedes mosquitoes, causes high morbidity rates with acute fever, joint and muscle pain, headache, nausea and rash.
Pierre Fabre Pharmaceuticals reports FDA acceptance and Priority Review of Tabelecleucel BLA
Bavarian Nordic's chikungunya vaccine receives validation from EMA for accelerated review
Atara Biotherapeutics gains FDA Priority Review for tabelecleucel
Hyperfine secures FDA clearance for faster brain imaging software
Silo Pharma agrees Alzheimer's drug licence
Kyverna's KYV-101 granted FDA Regenerative Medicine Advanced Therapy designation
Camurus reports positive Phase 3 ACROINNOVA 2 results
Acurx Pharmaceuticals presents positive Ibezapolstat Phase 2 clinical trial results for CDI