On February 11, 2022, the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) sent a letter to CytoDyn, Inc., over its investigational new drug leronlimab, currently under an investigational new drug application (IND). According to the letter, FDA takes issue with a video interview from September 2021, where Dr. Nader Pourhassan discusses leronlimab and represents – in a promotional context – that it is safe and effective for the purpose for which it is being investigated, or otherwise promotes the drug. Therefore, OPDP states, leronlimab is misbranded under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
According to OPDP, the video “makes conclusory representations in a promotional context regarding the safety and efficacy of leronlimab, an investigational drug, that has not been approved or authorized by the FDA and whose safety and efficacy has not yet been established.”
Concerning Statements Cited by OPDP
Some of the examples cited in the letter as claims that promote the drug as safe and effective for the purposes for which it is being investigated are:
- “In the United States, we did a trial of 394 patients which included severe and critically ill population. In the critically-ill population, our results were really strong…”
- “Our critically-ill population that we did in the United States when we gave a dose of leronlimab, the survival rate was 78%. Once we gave them another dose, the survival rate went up to 82%.”
- “Imagine, if 78% went to 82, the next one would be maybe 88, and then 95. I am making up numbers, but if it goes to that kind of numbers, if it just follows the same pattern what we learned, this is going to be the most fantastic results anybody could ever imagined to have. Now I’m not saying that’s what we’re going to get, but I’m saying that’s what the results are showing.”
- “The primary endpoint…is the discharge, the rate of patients who get on ventilator and get discharged. That endpoint was 166% better in our trial that we did in the United States versus placebo…166%.”
OPDP believes that the claims “make numerous conclusory statements” that suggest that the drug has been established as safe and effective against COVID-19, when in reality, it is an investigational new drug and its indications, warnings, precautions, adverse reactions, dosage, and administration, have not yet been established.
Concerns for Public Health
OPDP notes that the video is “concerning from a public health perspective” because it suggests that the drug provides a clinical benefit to patients suffering from COVID-19.
OPDP takes it a step further, though, and calls the video “extremely concerning” because it “significantly mischaracterizes the clinical trial data for leronlimab in the treatment of COVID-19, and the stated conclusions based on this mischaracterized data create a misleading impression regarding the safety and efficacy of the product.”
OPDP notes that the larger trial that CytoDyn conducted in patients with severe COVID-19 disease failed to find any effect of the drug on the primary study endpoint of Day 28 all-cause mortality (20.5% in the leronlimab treatment group and 21.6% in the placebo treatment group) or any predefined secondary endpoints.
Requested Action
As is typical, OPDP requested a response within 15 days from CytoDyn, asking that the company address the Agency’s concerns, list all other promotional communications for the drug that contain similar representations as those in the letter, and explain its plan for discontinuing the use of such communications or for stopping leronlimab distribution.
OPDP also asked that CytoDyn include a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective communications about the concerns raised in the Warning Letter, to the same audience that received the initial misleading video.