Japanese Drugmaker Shionogi Anticipates 2025 US Launch of Xocova COVID-19 Pill Amid Japan's Funding Cuts

By John Lopez

Mar 12 2024, 12:36 PM EDT

Japanese pharmaceutical company Shionogi is gearing up for the U.S. launch of its COVID-19 treatment, Xocova, anticipated in early 2025. This move comes as Japan cuts public funding for coronavirus medications, shifting the company's focus towards overseas markets.

Speaking with Nikkei Asia, Shionogi's President and CEO, Isao Teshirogi, expressed optimism about the U.S. launch, stating that a smooth review process by the U.S. Food and Drug Administration (FDA) could pave the way for approvals in other countries.

The company has applied for approval in South Korea and Singapore and plans to do so in the U.S. by June, benefitting from fast-track designation for expedited review.

Xocova's Accessibility

The efficacy of Xocova is eagerly awaited, with global clinical trial results for high-risk and other patients expected in April. In a significant development, Japan's Ministry of Health approved Xocova for manufacture and sale on Mar. 5. However, this approval coincides with the end of public funding for COVID treatments under Japan's national health insurance program.

Initially provided free of charge, Xocova's accessibility has changed since October 2023 when patients began shouldering part of the cost, which is set to rise to over 15,000 yen from April onwards. Despite this, Shionogi aims to expand Xocova's use to high-risk patients, underscoring its commitment to combating the pandemic.

Pfizer's COVID Pill

In parallel news from September 2023, Pfizer's drug Paxlovid, the world's first oral antiviral for COVID, showed a decline in real-world efficacy. A study published in JAMA Network Open revealed that Paxlovid was 37% effective at preventing hospitalization or death in high-risk patients, compared to an 89% efficacy rate in earlier trials.

However, Paxlovid maintained an 84% effectiveness against death alone, reinforcing its significance in managing severe COVID-19 cases. The study's lead author, Danyu Lin, emphasized the continued recommendation of Paxlovid for high-risk patients despite its reduced efficacy in real-world settings.