Eiger BioPharmaceuticals, Inc., a commercial-stage biopharmaceutical company focused on the development of innovative therapies for hepatitis delta virus (HDV) and other serious diseases, provided an update on the status of its planned request for emergency use authorization (EUA) of peginterferon lambda for the treatment of patients with mild-to-moderate COVID-19 based on its most recent communications with the U.S. Food and Drug Administration (FDA).
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Following a cooperative and extensive pre-EUA information exchange with 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. FDA has indicated that it will consider any new information and data from the TOGETHER study to support an EUA as well as the company’s plans for the further development of peginterferon lambda for COVID-19. Eiger remains in active dialogue with FDA and will provide additional information to the agency that the company believes could be supportive of an EUA.
“We appreciate the active dialogue with FDA and remain committed to continued engagement with the agency to obtain the necessary alignment to submit our EUA application for peginterferon lambda,” said David Cory, President and CEO, Eiger. “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.”
The company has recently 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 and is summarized