WASHINGTON– Federal regulators have authorized emergency use of another COVID-19 treatment, the anti-inflammatory drug baricitinib, to be used in combination with a drug already used to treat severely ill, hospitalized patients.
The Food and Drug Administration on Thursday cleared the new use for Eli Lilly’s pill baricitinib plus remdesivir for hospitalized adults and children two years and older requiring oxygen or ventilation therapy.
Remdesivir is the first and only drug approved by FDA to treat COVID-19. The emergency clearance for baricitinib acts as a preliminary approval until more data is available showing the drug works for COVID-19.
The FDA said the drug combination appeared to reduce recovery time in hospitalized patients, compared to patients who received only remdesivir.
The agency said ongoing research will be needed to confirm the benefit.
Indianapolis-based Lilly already sells baricitinib as Olumiant to treat rheumatoid arthritis, the less common form of arthritis that occurs when the immune system attacks joints, causing inflammation. An overactive immune system also can lead to serious problems in coronavirus patients.
The FDA based its decision on a 1,000-patient study in which patients were randomly assigned to receive the drug combination– baricitinib plus remdesivir– or remdesivir plus a placebo. The study was conducted by the National Institutes of Health.