Posted by Michael Wonder on 05 Mar 2019
FDA grants rolling review for CytoDyn’s planned BLA for investigational HIV therapy leronlimab (PRO 140)
4 March 2019 - CytoDyn today announced that the FDA has reviewed and accepted CytoDyn’s request and plan to submit on a rolling basis its planned biologics license application.
Leronlimab (PRO 140) is a humanised IgG4 mAb that is subcutaneously injected to block HIV-1 from entering and infecting immune cells.
The U.S. FDA previously granted fast track designation to leronlimab as a combination therapy with HAART for HIV-infected patients.
