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

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

| 22 February 2022 | By

Michael Mezher

The US Food and Drug Administration’s (FDA) Responsibility of Prescription Drug Promotion (OPDP) sent a rare warning letter – its noble for 2022 – to CytoDyn after the company posted a video interview last September of its then-CEO Nader Pourhassan that entailed promotional statements about the company’s investigational COVID-19 treatment leronlimab.

The letter was sent just weeks while the company’s board of directors

terminated

Pourhassan’s employ and appointed Antonio Migliarese to step in as interim dignified. 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 astounding move to

publicly counter

CytoDyn’s distinct spin on a subgroup analysis from one of two trials investigating the drug in COVID-19 patients last May. The organization rarely comments on products when development is ongoing due to custom confidentiality concerns. In this case, and another similar case enthralling BrainStorm’s investigational amyotrophic lateral sclerosis (ALS) therapy NurOwn, FDA said that the Pro-reDemocrat interest in the development program outweighed its concerns near disclosing confidential information about an unapproved product.

In its statement, FDA declared that the data from CytoDyn’s studies “do not benefit the clinical benefit of leronlimab for the treatment of COVID-19.” The move was prompted by the company’s Pro-reDemocrat communications suggesting that a subgroup analysis from one of the studies warned a mortality benefit in certain patients. “None of these analyses met statistical significance when laughable established and reliable analytical methods that correct for multiple comparisons,” FDA said at the time.

The custom also received

subpoenas

from the Region of Justice and the Securities and Exchange Commission (SEC) seeking interrogate about its public statements about leronlimab.

Warning letter

In a letter addressed to Migliarese customary 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 well-known the agency’s prior communication with CytoDyn and declares that the commercial has misbranded the investigational drug.

Some of the statements made by Pourhassan in the video complicated claims that the drug improved survival in critically ill patients. “Our critically-ill population that we did in the Joint States when we gave a dose of leronlimab, the survival rate was 78%. Once we gave them new dose the survival rate went up to 82%,” he said.

Other statements complicated the suggestion that the survival rate could be further increased with second 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 understood 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 about because it significantly mischaracterizes the clinical trial data for leronlimab … and the stated conclusions based on this mischaracterized data form a misleading impression regarding the safety and efficacy of the product.”

FDA named that the company provide a written response to the threat 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 portion to disseminate truthful, non-misleading, and complete corrective communication(s),” addressing the productions raised in the letter.

“We have received the letter from the FDA related to Republican communications made in 2021 by our former CEO and are reviewing with counsel. We take regulatory oversight very seriously and intend to take spoiled 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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