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The Food and Drug Administration (FDA) denied an emergency use authorization request for the drug COVID-19 from the biopharmaceutical company Humanigen.
Humanigen said in a statement Thursday that the FDA had denied the company’s request for authorization of emergency use of lenzilumab to treat newly hospitalized COVID-19 patients.
The company said the FDA was unable to conclude that the known potential benefits of the drug outweigh the known and potential risks of its use to treat coronavirus.
“We remain committed to bringing lenzilumab to patients hospitalized with COVID-19,” Humanigen CEO Cameron Durrant said in a statement.
Humanigen said additional data on the drug could support a new application for emergency use authorization.
“We believe that the ongoing ACTIV-5 / BET-B trial, which has been advanced to enroll up to 500 patients, may provide additional safety and efficacy data sufficient to support our efforts to achieve EUA to treat COVID-19 hospital patients, ”Durrant said.
The company said it remains committed to completing ongoing regulatory processes to obtain market authorization for lenzilumab to treat COVID-19 hospital patients in the UK and elsewhere.
The FDA granted emergency use authorization for Regeneron’s anti-COVID-19 antibody for injections in June.
Pfizer last week launched an advanced stage clinical trial for a pill that could potentially treat COVID-19 and will enroll 1,140 participants.
The United States has relied heavily on vaccines to fight the pandemic, as treatments are still under development.
Three COVID-19 vaccines are currently administered in the United States: Pfizer-BioNTech, Moderna and Johnson & Johnson.
More than 208 million people in the United States have received at least one dose of the COVID-19 vaccine, or 73.3% of the population aged 12 and older, according to the Centers for Disease Control and Prevention.
The vaccine has proven to be an effective tool for protection against serious illnesses linked to COVID-19: the majority of hospitalizations and recent deaths linked to the coronavirus have occurred in unvaccinated people.
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