Eiger BioPharma Shuns Plans For FDA Emergency Use Nod For COVID-19 Treatment

 

• Following FDA feedback, Eiger BioPharmaceuticals Inc (NASDAQ: EIGR) will not submit an emergency use authorization (EUA) application of peginterferon lambda for mild-to-moderate COVID-19.

• Following Eiger's press release in September, the company submitted a pre-EUA meeting request to FDA, as well as additional morbidity and mortality outcomes data and analyses from the investigator-sponsored TOGETHER study.

• 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 a EUA in the current context of the pandemic.

• 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).

• Eiger is evaluating the next steps for this program in the U.S., 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.

https://finance.yahoo.com/news/eiger-biopharma-shuns-plans-fda-135059064.html