FDA declines emergency use authorization for Humanigen COVID-19 drug
The Food and Drug Administration (FDA) has declined a request for emergency use authorization for biopharmaceutical company Humanigen’s COVID-19 drug.
Humanigen on Thursday announced in a statement that the FDA had declined the company’s request for emergency use authorization of lenzilumab to treat COVID-19 patients who are newly hospitalized.
The company said the FDA was unable to conclude that the known potential benefits of the drug outweigh the known and potential risks of using it to treat the 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 may support a new emergency use authorization request.
“We believe 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 obtain an EUA to treat hospitalized COVID-19 patients,” Durrant said.
The company said it remains committed to finishing regulatory processes underway to obtain marketing authorization for lenzilumab to treat hospitalized COVID-19 patients in the United Kingdom and elsewhere.
The FDA in June granted emergency use authorization for Regeneron’s COVID-19 antibody drug for injections.
Pfizer last week launched a later-stage clinical trial for a pill that could potentially treat COVID-19 and will enroll 1,140 participants.
The U.S. has been leaning heavily on vaccines to combat the pandemic as treatments are still in development.
Three COVID-19 vaccines are currently being administered in the U.S.: 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, amounting to 73.3 percent of the population ages 12 and older, according to the Centers for Disease Control and Prevention.
The vaccine has proved to be an effective tool in protecting against severe COVID-19 illness: The majority of recent coronavirus-related hospitalizations and deaths have been among individuals who are not inoculated.
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