Hope for Critically Ill Covid-19 Patients Within Reach

There is new hope for severely ill patients with Covid-19. On March 30th, US company CytoDyn, released results from a randomized, double-blind study of a drug called leronlimab. The study revealed an unprecedented 82% reduction in the rate of death at Day 14 for patients on a ventilator who received 2 weekly doses of leronlimab compared to a placebo.

To confirm the finding, CytoDyn will need to perform another trial that will take months to complete. In the meantime, the company asked FDA to approve access to leronlimab for critically ill patients now, under an Emergency Use Authorization or EUA.

Unfortunately, the FDA rejected that request. The consequences of that decision, both here and abroad, where regulatory agencies generally follow the FDA’s lead, will likely be devastating as new strains of mutant virus sweep the globe.

The FDA is given the authority to exercise judgement and approve emergency use of a treatment when evidence suggests it will provide more benefit than harm. The Agency has already approved EUAs for various antiviral therapies, all of which work in the early stages of Covid-19 illness. But, to date, there is still no emergency access to effective treatments for patients with advanced disease on a ventilator.

In contrast to traditional antiviral drugs, leronlimab is a monoclonal antibody that disrupts signals that create inflammation in the lungs and elsewhere in advanced illness. In one remarkable case, a patient on life support for 2 months was able to start weaning off that support just 4 days after receiving his first dose. Also, since leronlimab works by calming the immune system rather than attacking the virus itself, it should remain effective against mutant strains.

The FDA is understandably focused on safety as well as efficacy. But here, too, the agency’s decision is difficult to understand. Leronlimab has already been safely given to over 1200 patients, including those with HIV or cancer, as well as Covid-19. Some patients with HIV have received the drug by weekly injection for over six years without significant adverse effects. Equally important, the drug causes no harm in those patients it doesn’t appear to help.

We write today as two physicians who don’t have an equity interest in CytoDyn and have published in peer reviewed journals on the use of leronlimab in the ICU setting. The striking survival benefit seen in the recent CytoDyn study fully aligns with our own experience. We are convinced that leronlimab gives intubated patients and their medical teams a fighting chance.

The future of the pandemic remains uncertain. As the US reopens, we are already confronting a growing surge of mutant viral strains that are more infectious, probably more lethal, and likely a greater threat to younger individuals.

Current evidence clearly suggests that leronlimab is safe and can save lives. Indeed, it is the only drug to have demonstrated a survival benefit in critically ill patients with Covid-19 in a randomized, double-blind, placebo-controlled study.

We urge the FDA to issue an EUA for leronlimab now while confirmatory studies are completed. Hope and relief for the sickest and most vulnerable among us must not be withheld any longer.

Jacob Lalezari, MD, is Medical Director at Quest Clinical Research in San Francisco, CA. Harish Seethamraju, MD, is Professor of Medicine and director of the Lung Transplantation Program at Mount Sinai School of Medicine.