The FDA had indicated that it would not issue an emergency use authorization without additional data for peginterferon lambda to treat patients with mild-to-moderate COVID-19.
A month after the FDA said it was requiring additional data on Eiger BioPharmaceuticals’ request for emergency use authorization (EUA) of peginterferon lambda to treat patients with mild-to-moderate COVID-19, the pharma maker said it will not submit the EUA.
Following a pre-EUA information exchange with the FDA regarding the phase 3 TOGETHER study of peginterferon lambda for COVID-19, the agency indicated in September that it was not yet able to determine whether the criteria for the submission of an application and issuance of an EUA are likely to be met, Eiger said in a press release at the time.
The company then submitted a pre-EUA meeting request to FDA, as well as additional morbidity and mortality outcomes data and analyses from the TOGETHER study.
“This included further statistical modeling and efficacy analyses of the study's primary and secondary endpoints and long-term follow-up data that the company believes continue to support the initial positive topline outcomes reported in March,” Eiger said. “In response, FDA denied the request for a pre-EUA meeting.”
“Citing its concerns about the conduct of the TOGETHER study, FDA concluded that any authorization request based on these data is unlikely to meet the statutory criteria for issuance of an EUA in the current context of the pandemic,” Eiger added.
However, given peginterferon lambda's mechanism of action and the ongoing need for improved COVID-19 therapeutics, the FDA suggested that Eiger consider requesting an end-of-phase 2 meeting to discuss a company-sponsored pivotal trial that could support an eventual biologics license application (BLA).
“While we are disappointed that the 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,” David Cory, president and CEO of Eiger, said in a press release. "COVID-19 related deaths remain alarmingly high around the globe, including in the United States where, according to recent data from the Centers for Disease Control and Prevention, about 400 people die every day from this disease.”
Eiger officials said they are evaluating next steps for this program in the United States, as well as ex-U.S. emergency use authorization pathways and strategic options for continued development of peginterferon lambda for COVID-19 and other respiratory viral infections.
Eiger licensed worldwide rights to peginterferon lambda, an investigational late-stage, first-in-class, type 3 interferon (IFN) that stimulates immune responses that are critical for the development of host protection during viral infections, from Bristol-Myers Squibb.
Eiger is also developing peginterferon lambda to treat hepatitis D (HDV) infection. Peginterferon lambda has been administered to more than 4,000 subjects in 28 clinical trials of hepatitis B, hepatitis C, hepatitis D, and COVID-19.