The Food and Drug Administration (FDA) has rejected an application for emergency use authorization for the drug COVID-19 from the biopharmaceutical company Humanigen.
Humanigen announced Thursday in a statement that the FDA had rejected the application for lenzilumab emergency authorization to treat newly hospitalized COVID-19 patients.
The company said the FDA could not conclude that the known potential benefits of the drug outweigh the known and potential risks of using it to treat coronavirus.
“We remain committed to bringing lenzilumab to patients hospitalized with COVID-19,” Cameron Durrant, CEO of Humanigen, said in a statement.
Humanigen said additional data on the drug may support a new application for emergency use authorization.
“We believe the ongoing ACTIV-5 / BET-B trial, which has been advanced to enroll up to 500 patients, can provide additional safety and efficacy data sufficient to support our efforts to obtain a U.S. to treat patients. COVID-19 hospitalized “. Durrant said.
The company stated that it is committed to completing ongoing regulatory processes to obtain marketing authorization for lenzilumab to treat COVID-19 patients hospitalized in the UK and elsewhere.
The FDA granted emergency use authorization in June for Regeneron’s COVID-19 antibody drug for injections.
Pfizer last week launched a clinical trial at a later stage for a pill that could potentially treat COVID-19 and enroll 1,140 participants.
The United States has relied heavily on vaccines to fight the pandemic, as treatments are still in development.
Three COVID-19 vaccines are currently being administered in the US: Pfizer-BioNTech, Moderna, and Johnson & Johnson.
More than 208 million people in the U.S. have received at least one dose of the COVID-19 vaccine, which represents 73.3 percent of the population 12 years of age or older, according to the Centers for Disease Control and Prevention.
The vaccine has proven to be an effective tool in protecting against serious COVID-19 disease: most recent coronavirus-related hospitalizations and deaths have been among people who are not inoculated.