Shionogi, a leading Japanese pharmaceutical firm, is gearing up to introduce its innovative COVID-19 medication, Xocova, to the U.S. market by early 2025. This strategic move aligns with the company’s intensified focus on amplifying its international presence, especially as Japan concludes its public funding for COVID-19 treatments this month.
The anticipation builds as Shionogi’s President and CEO, Isao Teshirogi, shared with Nikkei the optimistic outlook for the drug’s approval process in the U.S., which could set a precedent, accelerating regulatory reviews in other nations. The firm is not just stopping at U.S. shores; it has already sought approvals in South Korea and Singapore, and the U.S. application is poised for submission by June, bolstered by a fast-track designation that promises an expedited review.
The global healthcare community is keenly awaiting the results from international clinical trials expected in April, which focus on high-risk and other patient groups. This follows the Japanese Health Ministry’s recent endorsement of Xocova, transitioning from emergency use to general approval, a significant leap forward in its accessibility.
However, Japan’s shift away from public funding for coronavirus medications, effective from the end of March, introduces new dynamics in the drug’s domestic market. Initially offered free, Xocova’s public support was tapered last October, leading to an out-of-pocket expense of up to 9,000 yen for patients. With the impending policy change, Japanese patients are bracing for increased costs, which will exceed 15,000 yen from April.
Despite these challenges, Shionogi remains hopeful about expanding Xocova’s application to a broader patient demographic, especially targeting those at high risk. The company’s strategic pivot towards global markets, starting with the U.S., signifies a crucial phase in its commitment to combating COVID-19 on a worldwide scale, leveraging its innovative pharmaceutical expertise.
