Valneva: FDA Fast Track status for Shigella4V
(CercleFinance.com) - Valneva and LimmaTech Biologics announce that they have received Fast Track status from the US FDA for Shigella4V (S4V), a tetravalent bioconjugate vaccine candidate against shigellosis, for which Valneva has obtained an exclusive worldwide license from LimmaTech.
Fast Track status is reserved for products in development targeting serious diseases that could meet an unmet medical need, and aims to facilitate their clinical development and registration with a view to making them available more rapidly.
Up to 165 million cases and around 600,000 deaths are thought to be attributable to shigellosis each year, particularly among children in low- and middle-income countries (LMICs), the companies said.
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