FDA: Eiger’s COVID-19 Treatment not Supported by Data

The FDA is requiring additional data and information on Eiger BioPharmaceuticals’ request for emergency use authorization (EUA) of peginterferon lambda to treat patients with mild-to-moderate COVID-19. Following a pre-EUA information exchange with the FDA regarding the phase 3 TOGETHER study of peginterferon lambda for COVID-19, the agency has indicated that it is not yet able to determine whether the criteria for the submission of an application and issuance of an EUA are likely to be met.

David Cory

“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,” David Cory, president and CEO of Eiger, said in a press release.

The company has generated new data and analyses from the TOGETHER study that it plans to discuss with FDA, including further statistical modeling and efficacy analyses of the study’s primary and secondary endpoints in patients treated within three days of symptom onset. The endpoint of hospitalization due to COVID-19 and all-cause mortality for patients treated within three days of symptom onset is consistent with the endpoint used to authorize other therapeutics for emergency use.

The original efficacy analysis of the data generated from the TOGETHER study was based on dosing peginterferon lambda within seven days of symptom onset. In March 2022, the company announced results from this study. In that analysis, peginterferon lambda reduced the risk of COVID-19-related hospitalizations or emergency room visits greater than six hours by 50% (the primary endpoint) and death by 60%.

Additionally, 2.7% of patients who received peginterferon lambda were hospitalized or had ER visits through day 28, compared with 5.6% of patients who received placebo. Peginterferon lambda achieved a 42% risk reduction for COVID-19-related hospitalizations when treated ≤7 days of symptom onset, as well as a 60% risk reduction when treated ≤3 days of symptom onset. In the trial, there was one COVID-19-related death in the peginterferon lambda group and four in placebo group.

Eiger also plans to provide the FDA new additional analyses of long-term follow-up data, including rates of rebound and incidence of long COVID, as well as an indirect comparative analysis of mortality and hospitalizations in vaccinated patients when treated with peginterferon lambda compared with other therapeutics authorized for emergency use.

Peginterferon lambda is a first-in-class, type III interferon (IFN) that stimulates immune responses that are critical for the development of host protection during viral infections. Eiger licensed worldwide rights to Lambda from Bristol-Myers Squibb.