Vaccine company Valneva SE (Nasdaq:VALN) (Euronext Paris:VLA) said on Wednesday that it has submitted label extension applications to the European Medicines Agency (EMA) and Health Canada to potentially expand the use of its chikungunya vaccine, IXCHIQ, to adolescents aged 12 to 17 years.
The applications include two-year antibody persistence data.
IXCHIQ is currently approved for adults in the United States, Europe and Canada. Valneva expects to submit data to the US Food and Drug Administration (FDA) this year to support potential label extensions in the United States. The company is also focused on expanding the vaccine's label and access in other regions, including Brazil.
The label extension applications are based on positive six-month adolescent Phase 3 data. Valneva expects to publish 36-month persistence data later this year.
GSK PLC announces acceptance of NDA for gepotidacin by US FDA
Sanofi in talks to sell Opella stake
Orlance receives research grant to develop Enhanced Seasonal Influenza Vaccine
MedImmune's FluMist nasal spray influenza vaccine receives US FDA approval
Gavi signs agreement with Bavarian Nordic for Mpox vaccines
Valneva seeks label extensions for chikungunya vaccine in Europe and Canada
MinervaX and Wacker Biotech collaborate on GBS vaccine manufacturing
Merck's GARDASIL 9 shows promise in preventing HPV infection in Japanese males
OSE Immunotherapeutics initiates Phase 3 trial for cancer vaccine Tedopi
Pfizer names new Regional President for Middle East, Russia and Africa
LakeShore Biopharma names new chief executive officer
Valneva and Pfizer report positive Phase 2 booster results for Lyme disease vaccine
Pfizer reports positive results for ABRYSVO RSV vaccine in immunocompromised adults