FDA dashes Eiger's EUA ambitions in COVID-19

Eiger BioPharmaceuticals’ (Nasdaq:EIGR) hopes of grasping an emergency use authorization (EUA) for peginterferon lambda as a treatment of patients with mild-to-moderate COVID-19 have been all but ended.

Last month, the US biopharma company submitted a pre-EUA meeting request to the US Food and Drug Administration (FDA), as well as additional morbidity and mortality outcomes data and analyses from the investigator-sponsored TOGETHER study.

" ... unlikely to meet the statutory criteria for issuance of an EUA in the current context of the pandemic"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 top-line outcomes reported in March.