CytoDyn Requests EUA for Leronlimab to Treat COVID-19 Patients

Vancouver, Wash.-based drugmaker CytoDyn is seeking an Emergency Use Authorization (EUA) from the FDA for its HIV treatment leronlimab for the treatment of mild-to-moderate COVID-19 patients.

CytoDyn CEO Nader Pourhassan announced the EUA application in an investor call while discussing top-line results of a phase 2 trial in which 90 percent of patients treated with leronlimab reported improvement in their symptoms compared to 71 percent of patients given a placebo.

By the end of treatment, patients given leronlimab were twice as likely to improve in their National Early Warning Scores — used to identify patients at risk for requiring critical care — compared to those who received a placebo, he said.

If granted, leronlimab would be the first drug authorized to treat mild-to-moderate COVID-19 patients and only the second COVID-19 treatment authorized overall. Gilead Sciences’ remdesivir is currently the only authorized COVID-19 treatment, but it is only authorized for patients with low blood oxygen levels or needing oxygen therapy or more intensive-breathing support (DID, May 4).

Pourhassan said the company is filing for emergency authorizations in “many different countries,” including the U.S. If no country grants an authorization, the company will conduct a phase 3 trial, he said. — Jordan Williams