The FDA authorized use of baricitinib (Olumiant), an oral Janus kinase (JAK) inhibitor, in combination with intravenous remdesivir (Veklury) to treat hospitalized patients with severe COVID-19, the agency said on Thursday.
The combination received emergency use authorization (EUA) for patients ages 2 and older who require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation, the FDA said in a statement.
Both drugs already have full approval from the FDA for other indications. Baricitinib was approved in 2018 for moderate to severe rheumatoid arthritis, and remdesivir was recently approved to treat hospitalized COVID-19 patients. Remdesivir is also authorized to treat pediatric patients weighing about 7 pounds to about 88 pounds with suspected or laboratory-confirmed COVID-19.
This is FDA’s first authorization of a drug for COVID-19 that acts on the inflammation pathway, said Patrizia Cavazzoni, MD, acting director of the FDA’s Center for Drug Evaluation and Research, in a statement. The agency noted that baricitinib is not authorized as standalone treatment for COVID-19.
“Despite advances in the management of COVID-19 infection since the onset of the pandemic, we need more therapies to accelerate recovery and additional clinical research will be essential to identifying therapies that slow disease progression and lower mortality in the sicker patients,” she added.
The EUA was granted based on data from the Adaptive COVID-19 Treatment Trial (ACTT-2), conducted by the National Institute of Allergy and Infectious Diseases. It was comprised of 1,033 patients with moderate or severe COVID-19: a total of 515 of whom received baricitinib with remdesivir and 518 who received placebo with remdesivir who were followed for 29 days.
Median time to recovery was 7 days for the intervention group compared with 8 days for the control group. Odds of progressing to death or being ventilated were lower and odds of clinical improvement at day 15 were higher for patients receiving the intervention compared with placebo, the agency said.
Topline results from this phase III trial were released on Sept. 14 in a press release from Eli Lilly and Incyte. Eli Lilly was granted the EUA.