Eli Lilly has picked up another win at the FDA, crossing the finish line again in the Covid-19 treatment race despite some mixed data. And the authorization comes before Regeneron’s antibody therapy, which notably was used to treat President Donald Trump back in October, could pick up an EUA.
Regulators have given the green light to Lilly’s Olumiant, in combination with Gilead’s remdesivir, to treat suspected or confirmed Covid-19 cases in both hospitalized adults and children over two that need supplemental oxygen, ventilators or life support. The authorization was based on data showing the median time to recovery from Covid-19 was seven days on the combo vs. eight days for remdesivir by itself.
“Based on the FDA’s review of the totality of the scientific evidence available, the agency has determined that it is reasonable to believe that baricitinib, in combination with remdesivir, may be effective in treating Covid-19 for the authorized population,” the FDA said in a statement.
Lilly revealed the data back in September, defining recovery as meeting the criteria for hospital discharge. They followed up in October saying the p-value was 0.047, with the benefits being most pronounced among patients needing supplemental oxygen or non-invasive ventilation at baseline.
The EUA comes amid broader questions regarding remdesivir’s effectiveness. Notably, a WHO trial showed the antiviral didn’t have any substantial effect on improving mortality rates, reducing the amount of patients needing ventilators or shortening hospital stays.
The FDA issued a full approval for remdesivir in late October on the basis of a separate trial, where the drug had “moderately reduced time to recovery.” That study, the NIAID-sponsored Phase III ACTT-1 trial published on Oct. 8, demonstrated a reduction in recovery time by five days in hospitalized Covid-19 patients and by seven days in patients requiring oxygen.
Regulators did consider the WHO trial in its decision to approve remdesivir, but said since Gilead’s ACTT-1 study was randomized, double-blinded and placebo-controlled whereas the WHO trial was open-label, they found ACTT-1 to be “better suited” in a time to recovery endpoint.
Olumiant, also known as baricitinib, is a JAK inhibitor used to treat rheumatoid arthritis, netting Eli Lilly nearly $450 million through the first three quarters of 2020. It was the first drug the NIH tested in combination immediately after finishing the remdesivir trial.
This is the second EUA Lilly has received in as many weeks, with regulators authorizing one of the company’s neutralizing antibody treatments less than ten days ago. Both Lilly and Regeneron, which is developing its own antibody treatment, revealed they applied for those EUAs on the same day.