CytoDyn’s Leronlimab Shows No Benefit for COVID-19 Infection, Says FDA

The FDA has refuted CytoDyn’s claims about the efficacy of the company’s experimental HIV drug leronlimab as a COVID-19 treatment based on data from two late-stage trials.

The FDA’s rebuke followed months of CytoDyn’s CEO Nader Pourhassan repeatedly offering statements about the therapy in press releases and interviews touting the therapy’s benefits.

In a rare direct statement posted online,the agency said data from two phase 3 trials showed the monoclonal antibody offered no benefit for treating mild-to-moderate and severe COVID-19 infections and that the drug was no more effective than a placebo.

“With the conclusion of [the two] clinical 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 agency said.