FDA authorizes emergency use of baricitinib plus remdesivir for COVID-19
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The FDA issued an emergency use authorization for baricitinib in combination with remdesivir for patients hospitalized with suspected or confirmed COVID-19, according to a press release.
The EUA is specifically for hospitalized adults and children aged 2 years or older who require supplemental oxygen, invasive mechanical ventilation or extracorporeal membrane oxygenation, the FDA noted.
“Today’s action demonstrates the FDA’s steadfast efforts to make potential COVID-19 treatments available in a timely manner, where appropriate, while continuing to support research to further evaluate whether they are safe and effective,” FDA Commissioner Stephen M. Hahn, MD, said in the release. “As part of our Coronavirus Treatment Acceleration Program, the FDA continues to use every possible avenue to facilitate new treatments for patients as quickly as possible to combat COVID-19.”
The FDA’s announcement follows recently announced ACTT-2 clinical trial data, which demonstrated that patients with COVID-19 who were treated with baricitinib (Olumiant, Eli Lilly) in combination with remdesivir (Veklury, Gilead Sciences) had a lower median time to hospital discharge and lower mortality rates than patients treated with remdesivir alone.
The ACTT-2 trial — a randomized, double-blind, placebo-controlled study conducted by the National Institute of Allergy and Infectious Diseases — followed 1,033 patients with moderate or severe COVID-19 for 29 days, with 515 patients treated with baricitinib plus remdesivir, and 518 receiving placebo plus remdesivir. The researchers defined recovery as either being discharged from the hospital or being hospitalized but not requiring supplemental oxygen and no longer requiring ongoing medical care.
According to the researchers, the median time to recovery from COVID-19 was 7 days for baricitinib plus remdesivir, and 8 days for placebo plus remdesivir. The odds of a patient’s condition progressing to death or being ventilated at day 29 was lower in the baricitinib plus remdesivir group, compared with the placebo plus remdesivir group. In addition, the odds of clinical improvement at day 15 was higher in the baricitinib plus remdesivir group, compared with the placebo plus remdesivir group. All of these findings were statistically significant, they said.
Currently approved for moderate to severe rheumatoid arthritis, baricitinib is now authorized to be used in combination with remdesivir, for the treatment of certain hospitalized patients with suspected or laboratory-confirmed COVID-19. However, the FDA’s EUA does not authorize or approve baricitinib as a standalone treatment for COVID-19.
Remdesivir is approved for use in adult and pediatric patients aged 12 years or older — and weighing at least 40 kilograms — for the treatment of COVID-19 requiring hospitalization. The drug remains authorized for emergency use for the treatment of suspected or laboratory-confirmed COVID-19 among hospitalized pediatric patients weighing 3.5 kg to less than 40 kg, or hospitalized pediatric patients aged younger than 12 years weighing at least 3.5 kg.
“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, MD, acting director of the FDA’s Center for Drug Evaluation and Research, said in the release. “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.”
Perspective
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Leonard H. Calabrese, DO
I am surprised at this rapid approval based on the minimal data provided thus far and eagerly look forward to the manuscript. For now, the effect sizes seem quite small (ie, 1-day overall reduction in recovery time and non-significant effect on survival [with positive trends]). I await further details on sub-analysis, including number needed to treat. I have already been called by a number of ID clinicians and intensivists today asking about this drug and this class.
To date, we have data from several small non-randomized trials demonstrating moderate effectiveness of baricitinib, a JAK1/2 inhibitor, which has in addition to its broad immunomodulatory effects on inflammation, additional effects on viral entry, which may be operative. This class of drugs, however, have significant adverse effect profiles including serious infections and thrombosis. I am most concerned now in how this this agent will be positioned vs. dexamethasone, for which the data are strong, particularly in patients with severe disease. I am sure there will be inclinations to combine these agents, which is very, very concerning in terms of untoward immunosuppression, and as far as I have seen, no guidance has been issued regarding this issue. As I said, I look forward to the data.
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