Shionogi Files Oral COVID Antiviral In Japan, Vaccine Shows Phase III Promise
Once-Daily Dosing Option
Shionogi announces plans to file for rapid Japan approval of S-217622, its once-daily oral therapeutic drug for COVID-19, while interim Phase III results show good efficacy for S-268019, its recombinant protein vaccine for SARS-CoV-2. Both are expected to be the first Japan-made solutions for the disease and could make a significant impact in the market.
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After months of speculation and anticipation, Shionogi’s once-daily oral antiviral for the treatment of COVID-19 has stumbled after receiving an unexpected preliminary decision on its emergency approval from an advisory committee in Japan.
Japan is intending to revise existing pharma legislation to enable the urgent approval of new drugs with "assumed efficacy", with a maximum three-year period for confirmation, in cases of emergency need. The government will also ask companies to implement tighter safety monitoring and management of supply chains, with swift data disclosure required, as part of the planned changes.
Japan has launched a new center to support vaccine and drug projects as a part of a larger scheme to tackle infectious disease. SCARDA will be in charge of establishing a flagship R&D site for innovative collaborations and controlling funds for R&D projects.