London, 05 May 2021: Eli Lilly announced today that baricitinib, the drug first identified as a COVID-19 treatment in February 2020 by BenevolentAI, has received permission for restricted emergency use in India from the Central Drugs Standard Control Organization, a division of the Ministry of Health. Eli Lilly is donating an initial 400,000 tablets baricitinib to the Indian government for immediate use in combination with remdesivir, and is simultaneously working with local Indian pharmaceutical companies to execute royalty-free voluntary licensing agreements to accelerate the manufacturing and distribution of the medicine across India.
“The catastrophic second wave of coronavirus in India has left soaring cases and record fatalities in its wake," commented Joanna Shields, CEO of BenevolentAI. “With hospitals across the country on the brink of collapse and oxygen in short supply, a deadly scenario is unfolding. We hope that immediate access to an oral, safe drug like baricitinib, which does not need to be administered in hospitals like other treatments, will immediately help save lives. Our strong partnership with Eli Lilly, their swift response to our initial hypothesis predicting baricitinib’s benefits for treating COVID-19 and results from subsequent trials have made this possible."
In January 2020, BenevolentAI scientists used its AI platform and biomedical Knowledge Graph to search for already approved drugs 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, at the time approved to treat rheumatoid arthritis, was identified as the most promising treatment from a list of thousands of potential drugs. During a 48 hour accelerated search process, the team uncovered baricitinib’s previously unknown anti-viral properties, in addition to it’s already known anti-inflammatory effects.
In February 2020, Benevolent published its findings in The Lancet and again in The Lancet Infectious Diseases proposing baricitinib as a COVID-19 treatment. By April, the National Institute of Allergies and Infectious Diseases (NIAID) in the US and Eli Lilly began its large-scale randomised COV-BARRIER trial, which demonstrated baricitinib reduces mortality in hospitalised COVID-19 patients by 38%; the most significant clinical effect for a reduction in mortality in this patient population reported to date.
Baricitinib was granted FDA emergency use authorisation (EUA) in November 2020 and is currently being administered to patients in the US alongside remdesivir. Last week, the European Union announced its decision to pursue EUA for baricitinib, and Japan announced it had approved baricitinib to treat COVID-19.
BenevolentAI creates and applies AI and machine learning to transform the way medicines are discovered and developed, integrating its technology into every step of the drug discovery process, from hypothesis generation to early-stage clinical development. Benevolent has active in-house R&D drug programmes in disease areas such as neurodegeneration, immunology, oncology, and inflammation and has research and commercial collaborations with leading pharmaceutical and research organisations. The company is headquartered in London with a research facility in Cambridge (UK) and a further office in New York.