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# FDA Agrees to Rolling BLA for CytoDyn HIV Therapy
- URL: https://www.fdaweb.com/fda-agrees-to-rolling-bla-for-cytodyn-hiv-therapy/
- Published: 2019-03-04T12:00:00.000Z
- Updated: 2026-09-15T01:09:29.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5143520

FDA has agreed to accept a CytoDyn rolling BLA submission for PRO 140 (leronlimab), a CCR5 antagonist, indicated for blocking HIV-1 from entering and infecting immune cells. Previously, the agency granted a fast track designation for leronlimab as a combination therapy with highly active antiretroviral therapy for HIV-infected patients.

Leronlimab is a monoclonal antibody intended to block CCR5, a cellular receptor that plays multiple roles with implications in HIV infection, tumor metastases and immune signaling, the company says. It has been studied in seven Phase 1/2/3 clinical trials in over 700 people, including, a successful pivotal Phase 3 trial in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients.