FDA 'Breakthrough' status for Valneva's chikungunya vaccine candidate

French vaccines developer Valneva (Euronext: VLA) has been awarded Breakthrough Therapy designation for its single-shot chikungunya vaccine candidate, VLA1553, by the US Food and Drug Administration (FDA).

Breakthrough Therapy designation intends to facilitate and expedite development and review of new drugs for serious or life-threatening conditions where preliminary clinical data demonstrates that the drug may have substantial improvement for at least one endpoint over available therapies. Chikungunya virus is spread to people by the bite of an infected mosquito.

This new US milestone comes in addition to the FDA Fast Track designation and the European Medicines Agency (EMA)’s PRIME designation which the company received in December 2018 and in October 2020, respectively.