The FDA’s Office of Prescription Drug Promotion (OPDP) issued its first Warning Letter of 2022 to CytoDyn Inc., over a video interview posted on the company’s website.

In the video, Dr. Nader Pourhassan, who was the company’s president and chief executive officer, discusses the investigational new drug leronlimab. “The video represents in a promotional context that leronlimab, an investigational new drug, is safe and effective for the purpose for which it is being investigated or otherwise promotes the drug,” the Warning Letter said. “The video is concerning from a public health perspective because it suggests that leronlimab provides a clinical benefit to individuals with COVID-19, which, in its most severe form, can result in respiratory failure and death. 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.”

OPDP noted that in May 2021, following public communications by CytoDyn regarding differences in small subgroups in one of the clinical trials CytoDyn conducted with leronlimab for the treatment of patients with COVID-19, including those with severe outcomes from COVID-19, the FDA issued a statement addressing CytoDyn’s development of leronlimab. The statement reviewed the results of two clinical trials, conducted by CytoDyn investigating leronlimab for the treatment of COVID-19. The statement concluded that with the conclusion of both trials, “it has become clear that the data currently available do not support the clinical benefit of leronlimab for the treatment of COVID-19.”

The Warning Letter said the video included claims that promoted leronlimab as safe and effective for the purposes for which it is being investigated or otherwise promote the drug, including the following examples:

• “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 percent. Once we gave them another dose, the survival rate went up to 82 percent.”
• “Imagine, if 78 percent went to 82 percent, the next one would be maybe 88 percent, and then 95 percent. 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 percent better in our trial that we did in the United States versus placebo … 166 percent.”

“The above claims make numerous conclusory statements that suggest that leronlimab has been established as safe and effective for the treatment of COVID-19. However, leronlimab is an investigational new drug, for which the product’s indication(s), warnings, precautions, adverse reactions, and dosage and administration have not been established,” the Warning Letter said.

OPDP added that the video was “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. As was noted in FDA’s May 17, 2021, statement, 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 percent in the leronlimab treatment group and 21.6 percent in the placebo treatment group) or any predefined secondary endpoints.”

“The suggestion that leronlimab has established ‘really strong’ results in the treatment and the ‘survival’ of critically-ill COVID-19 patients is especially troubling given the public health emergency related to COVID-19, the limited available treatment options, and the fact that COVID-19 is a disease that, in its most severe form, can lead to hospitalization, respiratory failure, and death,” the Warning Letter said.

“In summary, the video represents the drug as having an established role in the treatment of COVID-19, when leronlimab has not been proven as safe or effective within the meaning of the FD&C Act and has not been approved as a drug, nor granted an emergency use authorization under that authority for any use,” the letter concluded, adding “the claims in the video are concerning because they make representations in a promotional context regarding the safety and efficacy of an investigational new drug that has not been approved or authorized by the FDA.”

Editor’s note: All FDA Warning and Untitled Letters are available in Thompson Information Services’ FDA Enforcement Letter Database, which is available to subscribers of Thompson's FDA Compliance Expert.