FDA panel backs Takeda's maribavir in transplant patients with CMV infection

Takeda said that an FDA advisory committee unanimously voted in favour of approval of maribavir for the treatment of refractory cytomegalovirus (CMV) infection and disease with genotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir in transplant recipients. The panel also unanimously backed use of the antiviral for the treatment of refractory CMV infection and disease without genotypic resistance to the four drugs.

Obi Umeh, leader of Takeda's maribavir programme, noted that the positive vote "marks a significant step towards delivering the first approved treatment for adult transplant recipients with refractory CMV infection and disease, with or without resistance." The FDA granted maribavir's marketing application, which is based on data from the Phase III SOLSTICE trial, priority review in May.

Last year, Takeda announced that the SOLSTICE study met its primary endpoint, defined as the proportion of patients who achieved confirmed CMV viremia clearance compared to investigator assigned treatment, as well as its key secondary goal. Results reported earlier this year showed that 55.7% of patients treated with maribavir achieved confirmed CMV viremia clearance at week eight, versus 23.9% given conventional antiviral therapies. Further, 18.7% of those on maribavir maintained CMV viremia clearance and symptom control through week 16, compared to 10.3% of those administered conventional antiviral therapies.

Maribavir, also known as TAK-620 and SHP620, targets and inhibits the UL97 protein kinase and its natural substrates. Takeda gained the drug via its $62-billion purchase of Shire in 2019, with the latter itself acquiring the compound through its $4.2-billion acquisition of ViroPharma in 2014.

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