IMPORTANT CORRECTION OF INVESTIGATIONAL DRUG INFORMATION

On February 11, 2022, CytoDyn, Inc. received a Warning Letter from the U.S. Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion in which FDA asserted that statements made in a video created a misleading impression regarding the safety and efficacy of leronlimab.  Leronlimab is an investigational drug that has not been approved (or authorized) by the U.S. FDA for the treatment of COVID-19 or for any indication.  For more information, click here to access a Dear Healthcare Provider (DHCP) Letter: View Here.

HIV

A New Class of Antiviral Agents for HIV

Our lead product, leronlimab (PRO 140), belongs to a new class of HIV/AIDS therapeutics that protects healthy cells from viral infection. HAART, the current standard of care for HIV, waits until the virus enters the cell and begins replicating before it attacks the virus. 

Leronlimab’s Clinical Trial Performance

CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients meeting its primary endpoint. 81% of patients completing trial achieved HIV viral load suppression of < 50 cp/mL.

FDA Fast Track Designation for Leronlimab

CytoDyn has submitted the first two sections (non-clinical and CMC) of its Biological License Application (BLA) for that indication and our team is working diligently on the clinical section. The FDA previously granted Fast Track Designation (FTD) and granted Rolling Review for leronlimab (PRO 140), 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.

CytoDyn also completed an investigative monotherapy trial for HIV.

Get In Touch

For more information on leronlimab, our science, or our new developments, please reach out to us using the link provided.

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