OPDP Warning Letter Cites CEO’s COVID Claims in Video for IND

Feb. 28, 2022 – Comments made in a video interview by CytoDyn Inc.’s former president and CEO suggesting that the investigational new drug (IND) leronlimab provides a clinical benefit for those who have COVID-19 were the subject of the FDA Office of Prescription Drug Promotion’s (OPDP’s) first Warning Letter of 2022.

“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 have not been established,” OPDP’s Warning Letter states. It is worth noting that although it is uncommon for the agency to comment on INDs, it appeared to do so in this case because of the global COVID-19 pandemic.

The Feb. 11 enforcement letter states that the FDA “is taking measures to protect consumers from certain products that, without approval, clearance, or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.”

Last year, CytoDyn publicly communicated information about differences in small clinical trial subgroups for leronlimab, which prompted the FDA to issue a statement on May 17, 2021, that “none of these analyses met statistical significance when using established and reliable analytical methods that correct for multiple comparisons.” It also stated that “it has become clear that the data currently available do not support the clinical benefit of leronlimab for the treatment of COVID-19.”

The recent Warning Letter, sent to CytoDyn Interim President and CFO Antonio Migliarese, addresses a Sept. 22, 2021, video interview with Proactive Media featuring the company’s then-President and CEO Dr. Nader Pourhassan, who has since left the company. This video includes claims that promote leronlimab as safe and effective, including such phrases as “our results were really strong,” and “the survival rate was 78% … once we gave … another dose, the survival rate went up to 82%.” The video then suggested that additional doses could further improve survival rates, using qualifiers such as “I’m not saying that’s what we’re going to get”), and that the primary endpoint of hospital discharge “was 166% better in our trial that we did in the United States.”

These claims misbrand the IND, OPDP states, and the video “ is extremely concerning because it significantly mischaracterizes the clinical trial data for leronlimab in the treatment of COVID-19, and the stated conclusions based on the mischaracterized data create a misleading impression.” According to OPDP, “the video represents the drug as having an established role in the treatment of COVID-19, when [it] has not been proven as safe or effective … and has not been approved as a drug, nor granted an emergency use authorization … for that use.”

In addition to requesting a response to its concerns within 15 days, which is to include any documentation that supports the company’s statements, OPDP asks for a comprehensive plan of action for truthful communications moving forward and for corrective communications to those who received the cited video.

“Corrective communication(s) should be free of promotional claims and presentations,” OPDP states.