Sent 23 Dec. 2022 at 7:16 am
PARIS (Agefi-Dow Jones)–Valneva announced Friday that it has completed the submission of the US marketing authorization (MA) application for its single-shot chikungunya vaccine candidate, VLA1553, for people 18 years of age and older.
This marketing authorization application, filed with the Food & Drug Administration (FDA), the US health authority, follows final Phase 3 data published in March and final results of the clinical batch homogeneity trial published in May, the biotech company said .
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.
“The FDA will now review the dossier for acceptance, decide on the vaccine candidate’s eligibility for priority review and set the target date for completing its review,” Valneva said in a statement.
Since July 2021, Valneva’s vaccine candidate against chikungunya has benefited from “breakthrough therapy” status granted by the FDA. This status gives the company the right to accelerate the development of its product, which is intended to treat certain serious pathologies and for which preliminary data and clinical evidence indicate that it can provide a significant improvement over existing treatments.
The company whose chikungunya vaccine receives first marketing authorization in the United States will be eligible to receive a transferable Priority Review Voucher. It is a regulatory device to speed up the review process for drugs with a high probability of having a significant impact on the treatment of a disease. This voucher “can be sold to another company that wants to acquire it to speed up the review of a program by the FDA, without difference in technology or indication”, emphasizes Invest Securities.
The global market for chikungunya vaccines is estimated to exceed $500 million per year by 2032.
-Dimitri Delmond, Agefi-Dow Jones; +33 (0)1 41 27 47 31; [email protected] ed: VLV
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December 23, 2022 01:16 ET (06:16 GMT)