Differences in marketing of Maribavir at home and abroad

Maribavir (Maribavir), as an innovative antiviral drug targeting Cytomegalovirus (CMV) pUL97 kinase, has obvious differences in the pace of its launch in different regions around the world, reflecting the differences in understanding and approval strategies of countries in the treatment of CMV refractory infections after transplantation. Judging from the earliest overseas launch time, the U.S. FDA took the lead in approving the marketing of Maribavir in November 2021, under the trade name Livtencity, for the treatment of patients who are resistant to or fail to treat traditional anti-CMV drugs after transplantation. U.S. regulatory authorities usually grant rapid reviews in areas with significant unmet medical needs. This also makes maribavivir the first pUL97 kinase inhibitor, which is highly innovative in the antiviral field and therefore has a clear lead in approval speed in the United States.

Subsequently, the European Medicines Agency (EMA) approved the drug for marketing in November 2022, also using the trade name Livtencity. In the European Union's approval path, due to the regulatory system's emphasis on long-term risk verification and multinational joint assessment, its launch time is slightly later than that in the United States, but its indications and positioning are basically consistent with the FDA, and it mainly focuses on the patient group with refractory or drug-resistant CMV infection after transplantation. EU guidelines have long focused on the management of infections in the transplant population, particularly in patients with poor tolerance to traditional antiviral regimens, so the introduction of Maribavir in Europe is seen as an important addition to the treatment pathway.

China approved the marketing of maribavivir in December 2023, with the trade name "Yitaizhi", which was delayed by about two years compared with the overseas launch time. At the same time, China's diagnosis and treatment system for the management of post-transplantation infections has been rapidly improved in recent years, and unmet needs have been more clearly identified, making the launch of maribavivir of great significance. China is consistent with Europe and the United States in the scope of approved indications, emphasizing its use for CMV infections that have failed to be treated with traditional antiviral drugs (ganciclovir, valganciclovir, cidofovir, foscarnet), which means that the drug has filled the gap in the treatment of refractory CMV in China.

Reference materials:https://www.livtencity.com/