Learning and challenge of COVID-19 drug development in Japan through Baricitinib

抄録

From the outbreak of COVID-19, Eli Lilly has been dedicated globally to delivering treatment options against the disease which include baricitinib and neutralizing antibodies. COVID-19 is known to be associated with dysregulated inflammation. Baricitinib, an oral JAK1/2 inhibitor was identified as a potential treatment for COVID-19 among already approved and available drugs on market through artificial intelligence conducted by BenevolentAI. With that, phase 3 trial (the Adaptive COVID-19 Treatment Trial 2 (ACTT-2)) sponsored by National Institute of Allergy and Infectious Diseases (NIAID) began in May 2020 to assess the efficacy and safety of baricitinib plus remdesivir versus remdesivir in hospitalized patients with COVID-19. A total of 1,033 patients including one Japanese were randomized. The study met the primary endpoint of reduction of time to recovery in comparison with remdesivir. With the result, baricitinib received EUA (Emergency Use Authorization) in November 2020 in the US. In Japan, Eli Lilly Japan filed an application in December 2020 and the drug was approved in Apr this year. For now, baricitinib is an only approved drug for COVID-19 in Japan through a regular review process (remdesivir, casirivimab/imdevimab are available based on special approval). It was the first regulatory approval in the world for baricitinib though the drug became available in the US in November last year by Emergency Use Authorization system. After the approval and launch, as one of the safety risk management plans, Eli Lilly Japan is preparing for a Post Marketing Surveillance Study to confirm safety and efficacy of baricitinib in clinical use by enrolling 250 patients. In the future, it is hopeful to obtain the clinical data of the drug against COVID-19 for Japanese patients.