FDA Denies Emergency Use Authorization for New COVID-19 Drug

The Food and Drug Administration (FDA) headquarters in White Oak, Md., on Aug. 29, 2020. Andrew Kelly/Reuters

The U.S. Food and Drug Administration (FDA) has declined emergency use authorization for a lenzilumab monoclonal antibody drug to treat COVID-19, according to the developer of the drug.

Humanigen sought emergency use authorization for the medication to treat newly hospitalized COVID-19 patients. The company filed its petition with the drug regulator in May.

“In its letter, FDA stated that it was unable to conclude that the known and potential benefits of lenzilumab outweigh the known and potential risks of its use as a treatment for COVID-19,” the Burlingame, California-based firm said in a statement.

The head of Humanigen, Cameron Durrant, said that the company plans to keep trying to develop the drug.

“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 [emergency use authorization] to treat hospitalized COVID-19 patients,” he said.

COVID-19 is the disease caused by the CCP (Chinese Communist Party) virus.

Monoclonal antibody treatments for COVID-19 drew headlines last week after podcaster Joe Rogan wrote on social media that he contracted the virus and was taking monoclonal antibodies and a cocktail of other medications to treat it, although it’s not clear what exact medications Rogan took. Former President Donald Trump also took monoclonal antibodies from Regeneron when he contracted COVID-19 last year.

Rogan later confirmed on social media that he tested negative for the virus.

“Tested negative today! Thanks for all the kind wishes!” he wrote on Sept. 3

“We immediately threw the kitchen sink at it. All kinds of meds,” Rogan said two days prior to that, adding that he underwent the treatment for three days. “Monoclonal antibodies, ivermectin, Z-pak, prednisone, everything. And I also got an NAD-drip and a vitamin drip.”

The FDA is currently investigating the use of monoclonal antibodies to prevent CCP virus sufferers from being hospitalized. Monoclonal antibodies, which are commonly used to treat cancer patients, are proteins created in a laboratory that bind to specific substances in the body.

In May, the agency issued an emergency use authorization to GlaxoSmithKline for “monoclonal antibody therapy sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients,” according to a news release. In November, the FDA provided emergency authorization for casirivimab and imdevimab, also monoclonal antibodies, for the virus, according to a statement.

FDA officials didn’t immediately respond to a request by The Epoch Times for comment.