Valneva Says FDA Has Delayed Chikungunya Vaccine Review Date
August 14 2023 - 2:18AM
Dow Jones News
By Maitane Sardon
Valneva said Monday that the U.S. Food and Drug Administration
has delayed the target date for completing the regulatory review of
the marketing application for its chikungunya vaccine candidate to
the end of November, from end of August previously.
The French biotech company said the FDA extended the date to
allow sufficient time to align and agree on the phase 4 trial
program required under the accelerated approval pathway.
The FDA hasn't requested any additional clinical data for the
approval process, Valneva added.
Chikungunya is a viral disease transmitted by mosquitoes that
causes fever and joint pain, among other symptoms.
Write to Maitane Sardon at maitane.sardon@wsj.com
(END) Dow Jones Newswires
August 14, 2023 02:03 ET (06:03 GMT)
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