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Biotech


FDA NIXES EUA AMBITIONS FOR EIGER'S COVID TREATMENT, PROPOSES FULL APPROVAL
PATHWAY INSTEAD

By Max BayerOct 5, 2022 10:50am
Eiger BioPharmaceuticalsCOVID-19Food and Drug Administration (FDA)Prozac
Eiger's goal of reaching the clinical mountaintop has faltered after recent FDA
feedback. (Janoka82/Getty Images)

A month ago, Eiger BioPharmaceuticals was left in a state of limbo after muddled
conversations with the FDA about its COVID-19 treatment peginterferon lambda
meant the company was unable to discern whether it could nab emergency use
authorization. 




Those conversations have since been clarified. The problem for Eiger, however,
is that the FDA has made it clear that the EUA route is not on the table,
suggesting the company pursue full approval instead, according to a release
issued Wednesday. 




The company says that following its Sept. 6 release, in which it said it was
“not yet able to determine” whether or not it would meet EAU criteria, Eiger
requested a pre-EUA meeting with the FDA. The company also submitted additional
“morbidity and mortality outcomes data” from the investigator-sponsored Together
trial it was relying on. In response, the FDA said thanks, but no thanks,
denying the meeting request due to the “conduct” of the trial. 

The trial aims to asses already approved or under-development therapies as
COVID-19 treatments, including OCD treatment fluvoxamine, Prozac and Tarpeyo.
The primary endpoints were the change in emergency care, hospitalization and
death compared to placebo. 


RELATED

Murky FDA feedback leaves Eiger COVID treatment in regulatory limbo

In March, Eiger reported that peginterferon lambda reduced the risk of ER visits
longer than six hours by 50% compared to placebo. A total of 84% of treated
patients were at least partially vaccinated and the company said that the
treatment was also found to be effective against the Omicron variant.
Regardless, Eiger says the FDA relayed that an EUA was unlikely to be granted in
the “current context of the pandemic.” 



Instead, the agency suggested the company consider an additional pivotal trial
so it could take the full approval route, unlikely to be the most tantalizing
option given the cost of a new trial. The company said that as a result, it's
considering all options for peginterferon lambda, including emergency
authorization outside of the U.S. and “strategic options for continued
development” of the therapy. 


RELATED

Eiger eager to send COVID-19 drug to FDA after hospitalizations, deaths
slashed—including against omicron

In Wednesday’s release, Eiger CEO David Cory said the company was “disappointed”
and responded to the suggestion that the state of the pandemic factored into the
EUA decision. 

“COVID-19-related deaths remain alarmingly high around the globe, including in
the U.S. where, according to recent data from the Centers for Disease Control
and Prevention, approximately 400 people die every day from this disease," he
said. 

BiotechTarpeyo

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