Months into the COVID-19 pandemic, just two therapies have emerged as FDA-approved emergency therapies for hospitalized patients. Last month, Eli Lilly rolled out findings for rheumatoid arthritis med Olumiant in an effort to become the third—and new data show the extent of the drug's effect on improving recovery.
Lilly's Olumiant (baricitinib) added to Gilead Sciences' antiviral remdesivir cut COVID-19 patients' time to recovery by 12.5%—from eight days to seven days—over remdesivir alone and improved the odds of clinical improvement by 30% after 15 days of treatment, according to follow-up data from a National Institute of Allergy and Infectious Diseases (NIAID) study.
Olumiant performed the best in treating patients that required oxygen but had not yet progressed to the point of requiring high-flow oxygen or mechanical ventilation, Lilly said, but those data were not released Thursday.
Olumiant plus remdesivir also cut patients' death rates by 35% at the 29-day mark of treatment—an improvement over remdesivir alone but not to a significant degree, Lilly said. In patients requiring oxygen, Olumiant and remdesivir cut patients' death rates by 60%.
Lilly is still "continuing conversations" with the FDA about a potential emergency approval, the drugmaker said in a release. It revealed plans to pursue an emergency nod last month on the back of top-line data showing Olumiant's benefits on top of remdesivir.
In the U.S., only remdesivir and convalescent plasma are currently authorized to treat COVID-19. The latter therapy's FDA clearance spurred controversy, as many believed political pressure affected the review process. Before approving those treatments, the agency issued an emergency use authorization for hydroxychloroquine—a drug publicly touted by President Donald Trump—but later revoked it after controlled trials showed it wasn't effective.
Other rheumatoid arthritis therapies have chased that rarefied air in the first months of the COVID-19 pandemic but ultimately fell short, including competitors Kevzara from Sanofi and Regeneron and Roche’s Actemra. Both drugs failed their own pivotal studies, although Roche is still trialing Actemra in combination with remdesivir.
Soon after releasing top-line data, Lilly touted its drug as "extremely well-positioned" to roll out at a global scale given its small-molecule formulation and established use worldwide. The company could use its existing commercial channels and distribution systems for the medicine in COVID-19, Lilly Bio-Medicines President Patrik Jonsson said at the time.