FDA Grants EUA to Combination of Olumiant and Remdesivir in Hospitalized COVID-19 Patients
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The U.S. Food and Drug Administration granted Emergency Use Authorization to a combination of Eli Lilly’s and Incyte’s Olumiant (baricitinib), a rheumatoid arthritis treatment, and Gilead Sciences’ remdesivir as a treatment for hospitalized patients diagnosed with COVID-19 who require supplemental oxygen or ventilation.
The FDA granted EUA to the treatment based on clinical data that showed baricitinib, in combination with remdesivir reduced time to recovery within 29 days following treatment compared to remdesivir alone. The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated, the FDA said. Specifically, the EUA was authorized for patients two years of age and up with “suspected or laboratory confirmed COVID-19 who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).” Olumiant has not been approved by the FDA to treat COVID-19, and the efficacy, safety and optimal duration of treatment of baricitinib for COVID-19 have not been established. Remdesivir was granted EUA in May. This is the first combination regimen for COVID-19 authorized by FDA.
For Eli Lilly, the EUA marks the second asset given the green light as a treatment option for the novel coronavirus. Earlier this month, Indianapolis-based Eli Lilly and partner AbCellera won EUA for the investigational neutralizing antibody bamlanivimab (LY-CoV555). Bamlanivimab is a neutralizing IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, which should neutralize the virus, and potentially prevent and treat COVID-19. Bamlanivimab is derived from the blood of a recovered patient and was first discovered by AbCellera from the blood of one of the first recovered COVID-19 patients in the United States.
Eli Lilly Chief Executive Officer David Ricks said the EUA for Olumiant and remdesivir is an important milestone for hospitalized patients on oxygen. He said the addition of baricitinib may help speed the recovery of patients.
Olumiant is a once-daily, oral JAK inhibitor approved in the U.S. for the treatment of adults with moderately to severely active rheumatoid arthritis. It’s thought that inhibition of JAK 1 and JAK 2 may also play a role in reducing the cytokine storm associated with the most severe complications of COVID-19. In addition, Eli Lilly suspects Olumiant may have a role in inhibiting the host cell proteins that assist in viral reproduction, reducing the ability of infected cells to make more of the virus.
Data from the ACTT-2 study showed patients treated with the combination improved their median time to recovery from eight to seven days compared to remdesivir alone, a 12.5% improvement. The one-day reduction was considered statistically significant, Eli Lilly said when it announced the results. Also, the data showed the proportion of patients who progressed to ventilation, or died by Day 29, was 23% lower in the combination arm compared to remdesivir alone. Death by day 29 for these patients was reduced by 35% for the combination treatment compared to the Gilead drug alone.
The study also met a key secondary endpoint comparing patient outcomes at Day 15 using an ordinal 8-point scale ranging from fully recovered to death.
Incyte CEO Hervé Hoppenot said the company is pleased the FDA authorized the EUA to the combination treatment. He said the company is working toward other treatments for the global pandemic which had infected more than 56 million people across the globe and more than 11 million in the United States. There have been 1,356,952 people who have died from the disease, including 251,970 in the U.S.