Eiger BioPharmaceuticals has announced that it will not seek emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for peginterferon lambda to treat mild-to-moderate Covid-19 patients.
The decision to not submit the EUA application was made after receiving feedback from the FDA.
Last month, the company submitted a request to FDA for a pre-EUA meeting along with additional morbidity and mortality data obtained from the investigator-sponsored TOGETHER study.
However, that meeting was rejected by the regulator due to concerns about the conduct of the TOGETHER study.
The regulator noted that any authorisation request based on these data is not likely to meet the criteria to issue an EUA in the current context of the pandemic.
FDA suggested that the company needs to consider requesting a meeting for an end-of-Phase II to discuss a company-sponsored pivotal trial which can support an eventual Biologics License Application (BLA) for peginterferon lambda.
Eiger is currently evaluating the further steps for this programme in the US, and the pathways for ex- EUA in the country as well as the strategic options to continue the development of peginterferon lambda to treat Covid-19 and other respiratory viral infections.
Eiger president and CEO David Cory said: “While we are disappointed that FDA will not consider an EUA application based on results generated from the TOGETHER study, we continue to have strong conviction in the potential of peginterferon lambda to confer a meaningful benefit for patients with Covid-19 and other respiratory viral infections.
“Covid-19 related deaths remain alarmingly high around the globe, including in the US where, according to recent data from the Centers for Disease Control and Prevention, approximately 400 people die every day from this disease.”
The company is also advancing a late-stage multiple FDA Breakthrough Therapy designated programmes pipeline in Phase III, that include lonafarnib and peginterferon lambda to treat hepatitis delta virus (HDV), and avexitide for the treatment of congenital hyperinsulinism.
Furthermore, Eiger expects to report topline data from its Phase III study of lonafarnib-based regimens for HDV, D-LIVR, by the end of the year.