Posted by Michael Wonder on 18 Mar 2019
CytoDyn reaches historical milestone, submits first of three sections of BLA to FDA for leronlimab (PRO 140) as a combination therapy for HIV
18 March 2019 - FDA previously granted rolling review for BLA.
CytoDyn today announced that it has filed with the U.S. FDA the non-clinical portion of its biologics license application using the FDA’s rolling review process. The non-clinical portion constitutes the first of three sections of the BLA submission for leronlimab (PRO 140) as a combination therapy with HAART for HIV-infected patients.
The FDA previously granted fast track designation and recently granted rolling review for leronlimab (PRO140), which facilitates frequent interactions with the FDA review team. The Rolling Review process allows CytoDyn to submit individual sections of the BLA for review, rather than waiting on FDA review until all three sections are completed and filed.
