Eli Lilly, buoyed by Olumiant's COVID-19 data win, eyes emergency nod from FDA

Olumiant
Eli Lilly's Olumiant, approved in rheumatoid arthritis, improved recovery times in hospitalized COVID-19 patients. (Eli Lilly)

The pharma industry’s massive pandemic response may have yielded another winner, as Eli Lilly’s Olumiant—combined with Gilead’s remdesivir—improved recovery time in patients hospitalized with COVID-19.

In a trial run by the National Institute of Allergy and Infectious Diseases (NIAID), Lilly’s rheumatoid arthritis drug combined with Gilead’s antiviral helped patients recover faster than remdesivir alone by about one day. With those data, the company plans to pursue an emergency use authorization from the FDA. 

Olumiant also met a secondary endpoint in the trial by improving patient outcomes at day 15 on an eight-point scale. The NIAID ran the trial in more than 1,000 patients and expects to publish details in a medical journal, Lilly said. 

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In the U.S., only remdesivir and convalescent plasma have emergency use authorizations to treat COVID-19. The latter therapy's FDA clearance spurred controversy, as many believed political pressure affected the review process. Before those treatments, the agency had issued an EUA for hydroxychloroquine, a drug publicly touted by President Donald Trump, but later revoked it after controlled trials showed it wasn't effective.

That's not to say pharma companies and others haven't been hustling to find treatments. Since the outbreak began, scientists have started tests on hundreds of existing medicines in hopes that some can treat novel coronavirus infections. At the same time, companies are working to develop new medicines and vaccines against COVID-19. 

Many existing medicines, including other rheumatoid arthritis treatments such as Sanofi’s Kevzara and Roche’s Actemra, have failed studies in COVID-19. Roche is still pursuing Actemra in combination with Gilead’s remdesivir. 

RELATED: Gilead banks on blockbuster remdesivir with sunnier 2020 outlook 

Remdesivir, for its part, is one of the few medicines to show benefit in controlled COVID-19 studies. Gilead scored an emergency use authorization and is now expecting big sales for the medicine in the second half of the year. Steroids have also shown benefits in treating COVID-19.  

Looking forward for Olumiant, Lilly is assessing the data and whether it’ll affect an ongoing phase 3 study testing Olumiant alone versus background therapy in coronavirus patients. The company is also supporting investigator-run trials in Europe and North America.

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