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# No Pre-EUA for Eiger Covid Treatment
- URL: https://www.fdaweb.com/no-pre-eua-for-eiger-covid-treatment/
- Published: 2022-10-05T12:00:00.000Z
- Updated: 2026-09-14T18:01:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152898

FDA has denied an Eiger BioPharmaceuticals request for a pre-emergency use authorization (EUA) meeting on its potential application of peginterferon lambda to treat patients with mild-to-moderate Covid-19\. A company [statement](https://www.prnewswire.com/news-releases/eiger-biopharmaceuticals-provides-update-on-plans-for-emergency-use-authorization-application-following-fda-feedback-301641172.html?ref=fdaweb.com) says the agency cited concerns about the conduct of the TOGETHER study and said that any EUA request based on data from that study was unlikely to meet the statutory criteria for issuing an EUA in the current context of the pandemic.

Eiger says FDA suggested that it consider requesting an end-of-Phase 2 meeting to discuss a company-sponsored pivotal trial that could support an eventual BLA, given peg interferon’s mechanism of action and the ongoing need for improved Covid-19 treatments. The company says it is investigating its potential next steps.