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FDA grants EUA to baricitinib with remdesivir to treat COVID-19

The FDA has issued an Emergency Use Authorization for baricitinib in combination with remdesivir to treat COVID-19 in hospitalised patients.

The US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19. The drug combination will be administered to hospitalised patients requiring supplemental oxygen, invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).

In a clinical trial of hospitalised patients with COVID-19, baricitinib, in combination with remdesivir, was shown to reduce time to recovery within 29 days after initiating treatment compared to patients who received a placebo with remdesivir. The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated. 

“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,” said FDA Commissioner Dr Stephen Hahn. “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.”

Baricitinib is a janus kinase inhibitor, which blocks the activity of one or more of a specific family of enzymes, interfering with the pathway that leads to inflammation. Baricitinib is a prescription oral tablet medication that is FDA-approved (and sold under the brand name Olumiant) for the treatment of moderately to severely active rheumatoid arthritis. 

“The FDA’s emergency authorisation of this combination therapy represents an incremental step forward in the treatment of COVID-19 in hospitalised patients and the FDA’s first authorisation of a drug that acts on the inflammation pathway,” said Dr Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research. “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.”

The data supporting this EUA for baricitinib combined with remdesivir are based on a randomised, double-blind, placebo-controlled clinical trial (ACTT-2), which was conducted by the US National Institute of Allergy and Infectious Diseases (NIAID). This clinical trial evaluated whether baricitinib impacted how long it took for subjects who were also taking remdesivir to recover from COVID-19. The trial followed patients for 29 days and included 1,033 patients with moderate or severe COVID-19; 515 patients received baricitinib plus remdesivir and 518 patients received placebo plus remdesivir. Recovery was defined as either being discharged from the hospital or being hospitalised but not requiring supplemental oxygen and no longer requiring ongoing medical care. The median time to recovery from COVID-19 was seven days for baricitinib plus remdesivir and eight 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 versus the placebo plus remdesivir group. For all of these endpoints, the effects were statistically significant.

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