It’s not like the FDA to make a public statement about an unapproved drug. But after months of CytoDyn presenting a positive spin on a drug that flopped two COVID-19 trials, the agency apparently couldn’t take it anymore.
This week, the FDA released a “Statement on Leronlimab,” an antibody treatment that failed to meet its primary and secondary endpoints in two COVID-19 trials. The results of the two studies were reported in March and showed that the drug did not reduce symptoms or lower mortality.
Yet, since then, the company’s CEO has regularly promoted the drug as a potential COVID-19 therapy. His reasoning? When only looking at a subgroup of 62 patients, the company has said, the drug appeared to lower mortality by 24 percent.
In its statement, the FDA reminded the public about how clinical trials are designed — first the company selects its endpoints and then it uses pre-specified statistical methodologies to analyze the results. Post-hoc analysis that zeros in on one group of patients may help inform future clinical trials, but it does “not support reliable conclusions about the medicine’s benefit,” the agency said.
“Focusing on only the most favorable of many subgroup analyses, even if the sub-groups are pre-specified, can lead to overestimating the evidence of benefit, because regardless of a drug’s true efficacy, some analyses are likely to appear favorable by chance when a large number of analyses are conducted,” the agency said.
The FDA goes on to say that although CytoDyn has “has publicly communicated differences in small subgroups” from its trials, that “ it has become clear that the data currently available do not support the clinical benefit of leronlimab for the treatment of COVID-19.”
If CytoDyn wants to conduct further studies of the drug on COVID-19 patients? The FDA suggests that the company gets in touch.
Shares of CytoDyn plummeted by at least 26 percent after the FDA released its statement.
