A COVID-19 drug that works for all variants won't hit the market anytime soon — here's why

An experimental COVID-19 antiviral has been shown to cut the risk of hospital admission in half and appears to work across variants. Despite its promising attributes, it's unlikely to reach the U.S. market anytime soon because of regulatory challenges and a lack of funding, The New York Times reported Feb. 8. 

In a study published Feb. 9 in The New England Journal of Medicine, the drug — a pegylated interferon lambda injection  — was found to cut the risk of hospitalization or emergency room visit among mostly vaccinated individuals by 51 percent. Researchers compared more than 900 people who received the injection in Canada and Brazil to a control group who received a placebo. Less than 3 percent of people who received the antiviral were hospitalized, compared to 5.6 percent in the placebo group. The results were consistent across a number of variants. 

"Resistance due to variants or new strains of the virus could be an issue with some therapies, but this may not be a concern with peginterferon lambda due to its mechanism of action that involves activation of multiple virus-killing pathways," Jordan Feld, MD, associate professor of medicine at the University of Toronto and co-lead investigator, said in a Feb. 8 statement from Eiger BioPharmaceuticals, the drug's developer. 

Despite the results — and a shrinking landscape of COVID-19 treatments that are effective against newer variants — the drug is unlikely to be available in the U.S. due to regulatory hurdles with the FDA and a lack of funding, the Times reported. 

For one, the FDA told Eiger late last year it was not ready to issue an emergency authorization because the clinical trial did not include an American site. Regulators said a large clinical trial conducted at least in part in the U.S. that included more involvement from the company could work in the future, but Eiger executives said that would take several years and additional funding. 


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