Open Letter from Prominent Physicians Supports FDA Issuance of Emergency Use Authorization (EUA) for CytoDyn’s Monoclonal Antibody Leronlimab for Treatment of Critically Ill COVID Patients; “Drug Gives Intubated Patients a Fighting Chance,” Authors State

The following open letter to the FDA was posted on May 7, 2021 by two highly experienced and independent physicians: “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 the 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 [of leronlimab]. Also, because leronlimab works by calming the immune system rather than attacking the virus itself, it should remain effective against mutant strains.”
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