OPDP’s first warning letter of 2022 targets CytoDyn for COVID claims

Regulatory NewsRegulatory News | 22 February 2022 |  By 

The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) sent a rare warning letter – its first for 2022 – to CytoDyn after the company posted a video interview last September of its then-CEO Nader Pourhassan that included promotional statements about the company’s investigational COVID-19 treatment leronlimab.
The letter was sent just weeks after the company’s board of directors terminated Pourhassan’s employment and appointed Antonio Migliarese to step in as interim president. The letter marks only the second time OPDP has sent a warning letter over a company’s statements related to COVID-19. (RELATED: Misleading ads for asthma, weight loss meds garner warning letters, Regulatory Focus 5 October 2020)
The warning letter follows the agency’s extraordinary move to publicly counter CytoDyn’s positive spin on a subgroup analysis from one of two trials investigating the drug in COVID-19 patients last May. The agency rarely comments on products when development is ongoing due to commercial confidentiality concerns. In this case, and another similar case involving BrainStorm’s investigational amyotrophic lateral sclerosis (ALS) therapy NurOwn, FDA said that the public interest in the development program outweighed its concerns about disclosing confidential information about an unapproved product.
In its statement, FDA declared that the data from CytoDyn’s studies “do not support the clinical benefit of leronlimab for the treatment of COVID-19.” The move was prompted by the company’s public communications suggesting that a subgroup analysis from one of the studies showed a mortality benefit in certain patients. “None of these analyses met statistical significance when using established and reliable analytical methods that correct for multiple comparisons,” FDA said at the time.
The company also received subpoenas from the Department of Justice and the Securities and Exchange Commission (SEC) seeking information about its public statements about leronlimab.
Warning letter
In a letter addressed to Migliarese dated 11 February 2022, FDA said that a video interview posted to CytoDyn’s website late last year represents leronlimab in a promotional context and suggests that it is safe and effective at treating COVID-19, despite not being authorized or approved for such use.
The warning letter noted the agency’s prior communication with CytoDyn and declares that the company has misbranded the investigational drug.
Some of the statements made by Pourhassan in the video include claims that the drug improved survival in critically ill patients. “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%,” he said.
Other statements included the suggestion that the survival rate could be further increased with additional doses of the drug, and that those who were given the drug had a higher discharge rate than those given a placebo.
Those claims, FDA wrote, “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.”
FDA goes on to write that the video is “extremely concerning because it significantly mischaracterizes the clinical trial data for leronlimab … and the stated conclusions based on this mischaracterized data create a misleading impression regarding the safety and efficacy of the product.”
FDA requested that the company provide a written response to the warning letter within 15 working days that includes a list of all violative communications for leronlimab and detailing a plan for discontinuing such communications or ceasing the product’s distribution. The agency also asks the company to provide a “comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective communication(s),” addressing the issues raised in the letter.
“We have received the letter from the FDA related to public communications made in 2021 by our former CEO and are reviewing with counsel. We take regulatory oversight very seriously and intend to take appropriate corrective actions to ensure compliance. We will provide a further update in due course,” a CytoDyn spokesperson told Focus.
Warning Letter


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