Shionogi receives Fast Track Designation by FDA for Ensitrelvir Fumaric Acid, an Investigational Oral Antiviral for COVID-19
Shionogi announced that the FDA has granted Fast Track designation for their investigational COVID-19 oral antiviral ensitrelvir. The Fast-Track Designation of XOCOVA is designed to facilitate its development and expedite its review to fulfill the unmet need in COVID-19 outpatient treatments.
Ensitrelvir is an oral antiviral agent administered once daily for five days that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.
Ensitrelvir, known as Xocova 125 mg tablet in Japan, recently received emergency regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for the treatment of SARS-CoV-2 infection.
Shionogi recently presented results from the Phase 3 part of the pivotal SCORPIO-SR trial (Phase 2/3 study) conducted in Japan, South Korea, and Vietnam at the Conference on Retroviruses and Opportunistic Infections (CROI). Several additional Phase 3 clinical studies evaluating the safety and efficacy of ensitrelvir across a wide range of COVID-19 patient populations are planned and ongoing.
Implications
FDA will likely consider and review Shionogi's data first from the ongoing, global Ph3 SCORPIO-HRtrial in non-hospitalized patients followed by the Ph3 STRIVE trial in hospitalized patients.
Pending positive data and FDA EUA/NDA filing, XOCOVA remains on track to receive FDA authorization ahead of obeldesivir in non-hospitalized and hospitalized treatment settings.
Current timeline project XOCOVA could receive FDA EUA authorization 1H 2024 and NDA approval early 2025