Murky FDA feedback leaves Eiger COVID treatment in regulatory limbo

Nearly six months after Eiger Biopharmaceuticals posted encouraging phase 3 data on its COVID-19 treatment, the company says regulators have yet to indicate whether the med has a path forward to authorization.

After “extensive” conversations with the FDA, Eiger still doesn’t know whether it will meet the necessary requirements to submit, and ultimately nab, emergency authorization for peginterferon lambda, according to a release Tuesday. The company has answered six full information requests from the FDA since posting top-line data in March, including additional details on the investigator-led trial Eiger relied on, Eiger spokesperson Sarah Mathieson told Fierce Biotech via email. 

To submit an EUA at this point in the COVID-19 pandemic, the company needs "alignment and an ‘EUA number’ from FDA," Mathieson explained. Right now, she added, Eiger does not yet have alignment with regulators, but they remain "committed to work with Eiger to expedite its further development in COVID-19."  

Nonetheless, the update describes a particular regulatory purgatory for the COVID therapy without much of an escape route. The news sent the company’s shares tumbling, down more than 29% at the time of publishing, from $8.55 per share to $6.04. In a release, Eiger boss David Cory said the company would “remain committed” to ongoing conversations in order to satisfy regulators’ needs. 

"Given its unique mechanism of action and the ongoing need for effective COVID-19 therapeutics, making peginterferon lambda available for patients remains a priority for Eiger,” he said. 

In March, Eiger reported that the treatment cut the risk of COVID-19 hospitalizations or ER visits longer than six hours by 50% compared to placebo when taken within a week of symptom onset. The treatment was also found to be effective in the dominant omicron variant. The vast majority of recruited patients—84%—had at least one dose of a COVID vaccine, providing additional context on the treatment’s effectiveness in a population with some semblance of immunity. 

And it appears that Eiger is whipping up additional long-term data, compiling statistics on rebound cases of COVID-19 following treatment and incidence of long COVID. It’s not clear whether these were data that the FDA requested or whether the company is looking to grease the gridlock on its product. 

Eiger’s data came from a larger study—called TOGETHER—assessing existing or already-developed treatments for COVID-19. Included alongside peginterferon lambda, which Eiger is also developing to treat hepatitis delta virus, are the OCD treatment fluvoxamine, the antidepressant Prozac and budesonide. The trial is being conducted across 12 sites in Brazil and, according to the clinical trial record, is still recruiting. Eiger says it's working with trial investigators to have its data published in a manuscript.