TOPLINE The Food and Drug Administration Thursday issued an emergency use authorization for Eli Lilly’s rheumatoid arthritis drug baricitinib and remdesivir for coronavirus treatment, the first drug combination authorized by the FDA as a therapeutic for the virus.
Baricitinib is an existing FDA-approved drug for rheumatoid arthritis, but it has benefits for coronavirus patients used in combination with Gilead Sciences’ remdesivir, which has already been given full FDA approval.
The emergency authorization only applies to hospitalized patients in need of supplemental oxygen.
The drug combination was given emergency approval based on a randomized double-blind trial that found it reduced median recovery time by one day and increased the chances of survival by 35% compared to patients taking remdesivir alone.
Scientists are also interested in the combination of baricitinib and the steroid dexamethasone, the latter of which was taken by President Donald Trump when he was infected, as a potential coronavirus therapeutic.
“The FDA’s emergency authorization of this combination therapy represents an incremental step forward in the treatment of COVID-19 in hospitalized patients, and FDA’s first authorization of a drug that acts on the inflammation pathway,” Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
Eli Lilly has also earned emergency approval for bamlanivimab, a monoclonal antibody treatment for early cases of Covid-19. Other promising therapeutics, including Regeneron’s antibody cocktail and dexamethasone have yet to receive FDA approval. Hydroxychloroquine had its emergency authorization rescinded after data showed it had no benefit for Covid-19 patients.
WHAT TO WATCH FOR
Eli Lilly is conducting a clinical trial for baricitinib by itself, and the company may pursue an emergency use authorization for the drug depending on the results.
-By Rachel Sandler, Forbes Staff
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