PARIS (Agefi-Dow Jones)–Valneva announced Thursday evening that it has started submitting the marketing authorization (MA) application file to the American health authority (FDA) for its injection vaccine candidate against chikungunya (VLA1553) in people aged 18 and over.
This MA application follows the final Phase 3 data announced last March and the final results of the clinical batch homogeneity trial announced last May, the biotechnology company said.
A clinical study of VLA1553 in adolescents is ongoing in Brazil, to potentially allow for future regulatory submissions regarding this age group if VLA1553 is approved for use in adults.
Valneva expects to complete the submission of the dossier by the end of 2022.
“Once all elements of the application for authorization have been submitted and if the dossier is accepted, the FDA will make a decision on the candidate vaccine’s eligibility for priority review, which will determine the date that the FDA will target to complete its assessment,” added Valneva.
-Vincent Alsuar, Agefi-Dow Jones; +33 (0)1 41 27 47 39; [email protected] ed: VAT
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August 18, 2022 12:34 ET (16:34 GMT)