The US Food and Drug Administration has rejected Eiger BioPharmaceuticals' request to meet with the agency regarding peginterferon lambda, its repurposed hepatitis D treatment for use in COVID-19. The company asked for the meeting to discuss an emergency use authorization in September based on data from the TOGETHER Phase III trial. However, it appears the data was insufficient for the agency.
According to Lei Lei Wu, “Eiger said that the FDA suggested requesting a meeting following a Phase II trial that could support an eventual BLA. Eiger had previously attempted to run two Phase II trials with Johns Hopkins and Massachusetts General Hospital on peginterferon lambda for Covid-19, but stopped both studies because of low enrollment, according to clinicaltrials.gov. And two other previously completed Phase II trials had conflicting results — with one suggesting the treatment helped patients clear the virus faster and the other suggesting the treatment had no significant impact.”
To read more, click here.
(Source: Endpoints News, October 5th, 2022)