The rheumatoid arthritis drug, owned and marketed by Eli Lilly (NYSE: LLY) under the brand name Olumiant, is now authorised for use in hospitalised COVID-19 patients who require supplemental oxygen or invasive mechanical ventilation.
This EUA decision was based on data from clinical updates released from the NIAID ACTT-2 trial and further validates the AI-derived hypothesis of baricitinib as a potential treatment for COVID-19, first published by BenevolentAI in The Lancet on February 4, 2020.
The speed at which baricitinib entered clinical trials reflected the urgency of the pandemic and is testament to the strength of BenevolentAI's initial hypothesis.
This action from the FDA for the EUA of baricitinib is an important milestone that has progressed at an unprecedented pace, moving from computer to bench to bedside in nine months.
Ahead of a full analysis expected to be published imminently in a peer-reviewed journal from NIAID and study investigators, the key findings and scientific evidence supporting this EUA include the phase III ACTT-2 trial showed the proportion of patients who progressed to ventilation (non-invasive or invasive) or died by Day 29 was lower in baricitinib in combination with remdesivir compared to remdesivir alone.
There was a 35% lower mortality rate overall in the group taking baricitinib (5.1% vs 7.8%).
This reduction in mortality was more pronounced in patients receiving oxygen, as mortality at Day 29 was 60% lower for those on supplemental oxygen, and 43% lower for those on high-flow oxygen/non-invasive ventilation.
The trial met the primary endpoint of reducing time to recovery (discharge from hospital) by one day (12.5%) compared to remdesivir alone.
The most significant benefits were observed in patients requiring supplemental oxygen and in those needing high-flow oxygen/non-invasive ventilation.
The FDA grants Emergency use authorisation to provide availability of a medicine that may help diagnose, treat or prevent a life-threatening disease when no adequate and approved alternatives are available.
The recommended dose for this EUA is baricitinib 4-mg once daily for 14 days or until hospital discharge.
The ACTT-2 randomised control trial included more than 1,000 patients. It began on May 8 to assess the efficacy and safety of baricitinib plus remdesivir versus remdesivir alone in hospitalised patients with COVID-19 and was conducted in 8 countries, including the UK.
Baricitinib is approved for the treatment of rheumatoid arthritis and other diseases. It is administered orally and has been used to treat COVID-19 patients in more than 14 clinical trials worldwide, including a randomised clinical trial by NIAID.
Eli Lilly is conducting a Phase 3 randomised, double-blind, placebo-controlled study (COV-BARRIER) to evaluate the efficacy and safety of baricitinib in hospitalised adults with COVID-19.
BenevolentAI's research on baricitinib as a treatment for COVID-19 has been published in The Lancet, The Lancet Infectious Diseases, EMBO Molecular Medicine, and Science Advances.
BenevolentAI creates and applies AI and machine learning to transform the way medicines are discovered and developed.
Quanterix partners with leading health networks for Alzheimer's diagnosis advancements
Precision BioSciences reports FDA pre-IND feedback for PBGENE-HBV
VBI to sell manufacturing capabilities and enter new license agreement with Brii Biosciences
Ondine Biomedical's Steriwave shows promise in nasal pathogen reduction
BioSenic expands patent coverage for ATO therapeutic platform
PacBio unveils Nanobind PanDNA kit for enhanced DNA extraction solutions
Sequentify receives funding from Israel Innovation Authority
INOVIO plans BLA submission for INO-3107 as RRP treatment
ImmunityBio secures USD320m investment from Oberland Capital
Poolbeg Pharma prioritises promising RSV drug candidates identified through AI-led analysis
GHIT fund invests JPY500m in antimalarial drug clinical trial
AstraZeneca agrees acquisition of Icosavax
Versameb names new chairman of the board
Kling Bio appoints Dr Stefano Gullà as chief scientific officer