FDA nixes EUA ambitions for Eiger's COVID treatment, proposes full approval pathway instead

A month ago, Eiger BioPharmaceuticals was left in a state of limbo after muddled conversations with the FDA about its COVID-19 treatment peginterferon lambda meant the company was unable to discern whether it could nab emergency use authorization. 

Those conversations have since been clarified. The problem for Eiger, however, is that the FDA has made it clear that the EUA route is not on the table, suggesting the company pursue full approval instead, according to a release issued Wednesday. 

The company says that following its Sept. 6 release, in which it said it was “not yet able to determine” whether or not it would meet EAU criteria, Eiger requested a pre-EUA meeting with the FDA. The company also submitted additional “morbidity and mortality outcomes data” from the investigator-sponsored Together trial it was relying on. In response, the FDA said thanks, but no thanks, denying the meeting request due to the “conduct” of the trial. 

The trial aims to asses already approved or under-development therapies as COVID-19 treatments, including OCD treatment fluvoxamine, Prozac and Tarpeyo. The primary endpoints were the change in emergency care, hospitalization and death compared to placebo. 

In March, Eiger reported that peginterferon lambda reduced the risk of ER visits longer than six hours by 50% compared to placebo. A total of 84% of treated patients were at least partially vaccinated and the company said that the treatment was also found to be effective against the Omicron variant. Regardless, Eiger says the FDA relayed that an EUA was unlikely to be granted in the “current context of the pandemic.” 

Instead, the agency suggested the company consider an additional pivotal trial so it could take the full approval route, unlikely to be the most tantalizing option given the cost of a new trial. The company said that as a result, it's considering all options for peginterferon lambda, including emergency authorization outside of the U.S. and “strategic options for continued development” of the therapy. 

In Wednesday’s release, Eiger CEO David Cory said the company was “disappointed” and responded to the suggestion that the state of the pandemic factored into the EUA decision. 

“COVID-19-related deaths remain alarmingly high around the globe, including in the U.S. where, according to recent data from the Centers for Disease Control and Prevention, approximately 400 people die every day from this disease," he said.