Vaccine development company Valneva 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.
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.
Juan Carlos Jaramillo, Chief Medical Officer of Valneva commented: “We are extremely pleased with FDA’s recognition of VLA1553 as a Breakthrough program. Chikungunya is a major, growing public health threat and VLA1553 targets long lasting protection against the chikungunya virus with a single shot. We will continue to work closely with the FDA to bring a preventative solution to the market as soon as possible.”
Valneva announced recruitment completion for its pivotal Phase III trial, VLA1553-301, in April 2021 and expects to report topline data this summer. The primary objective of the trial is to evaluate the immunogenicity and safety of VLA1553 at 28 days following a single immunisation.
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