Friday, October 15, 2021

US FDA EUA for baricitinib+remdesivir combo for COVID-19 – Express Healthcare



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Possible side effects of baricitinib in combination with remdesivir include serious infections, blood clots, changes in certain lab test results and allergic reactions

The US Food and Drug Administration issued an emergency use authorisation (EUA) for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalised adults and paediatric patients two years of age or older 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. Baricitinib is not authorised or approved as a stand-alone treatment for COVID-19. The EUA was issued to Eli Lilly.

Possible side effects of baricitinib in combination with remdesivir include serious infections, blood clots, changes in certain lab test results and allergic reactions.

Under the EUA, fact sheets that provide important information about using baricitinib in combination with remdesivir in treating COVID-19 as authorised must be made available to health care providers and to patients and caregivers. These fact sheets include dosing instructions, potential side effects and drug interactions.



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