FDA Grants Emergency Use Authorisation For Baricitinib In Hospitalised COVID-19 Patients Nine Months After Initial Hypothesis Was Published By BenevolentAI

• Baricitinib was identified by researchers at BenevolentAI as a potential treatment for COVID-19 in early February 2020  
• The FDA authorisation enables immediate use of baricitinib in combination with remdesivir to treat hospitalised COVID-19 patients 
• ACTT-2 data demonstrated baricitinib improved clinical outcomes and increased recovery rates of hospitalised COVID-19 patients
• There was a 35% lower mortality rate overall in the group taking baricitinib (5.1% vs 7.8%)

London, 20 November 2020: BenevolentAI announced today that baricitinib, a drug it first identified as a potential treatment for COVID-19 by the company has been granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA). The rheumatoid arthritis drug, owned and marketed by Eli Lilly 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 https://www.benevolent.com/news/benevolentais-platform-derived-hypothesis-for-covid-19-treatment-validated-in-us-niaid-randomised-control-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.

Joanna Shields, CEO of BenevolentAI commented: “I am immensely proud that our research is playing a part in the global fight against COVID-19. The NIAID ACTT-2 trial data confirmed our initial hypothesis that baricitinib could be an effective treatment for hospitalised patients with COVID-19. With infection rates soaring, physicians will now have this valuable treatment in their armamentarium to combat the deadly virus.”

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 (23%) compared to remdesivir alone (28%).
• 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.