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FDA converts emergency approval of baricitinib — first identified as a COVID treatment by BenevolentAI — to a full approval

The U.S. Food and Drug Administration (FDA) has approved baricitinib to treat COVID-19 in hospitalised adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has been available in the U.S. under Emergency Use Authorization (EUA) since November 2020. The full approval underscores the strength of BenevolentAI’s initial AI-derived hypothesis, which first identified baricitinib as a potential treatment for COVID-19.

On the 5th of May 2022, the NHS also announced it has rolled out access to baricitinib for the treatment of COVID-19 patients. These developments broaden access to the life-saving benefits of baricitinib for seriously ill COVID-19 patients in both the UK and US. 

In January 2020, scientists at BenevolentAI used artificial intelligence (AI) to first identify baricitinib as a COVID-19 treatment in just 48 hours. BenevolentAI researchers used its AI platform and biomedical Knowledge Graph to search for already approved drugs that could be used to treat the virus. The scientists focused on discovering a potential treatment that could both inhibit viral entry into cells, and deliver an anti-inflammatory effect to reduce the body’s extreme immune response known as the cytokine storm. Baricitinib, an oral JAK inhibitor, owned by Eli Lilly and approved for rheumatoid arthritis, was rapidly identified as the most promising treatment from a list of thousands of potential drugs. The team also used this AI-enhanced approach to discover that baricitinib had previously unknown antiviral properties, in addition to its already known anti-inflammatory effects. BenevolentAI’s research was first published in The Lancet and The Lancet Infectious Diseases in February 2020. 

Baricitinib has since been repeatedly proven to save lives when given to the most seriously ill COVID-19 patients, including in the NIAID ACTT-II trial, the UK’s RECOVERY trial and the COV-BARRIER trial. Data from Eli Lilly’s placebo-controlled trial, COV-BARRIER, showed baricitinib reduced deaths in hospitalised COVID-19 patients by 38%, the most significant clinical effect reported to date for reduction in mortality for this patient population. Baricitinib has been strongly recommended by the World Health Organisation (WHO) at its highest evidence level in the BMJ Living Review.

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