New Phase III data show TAK-620 (maribavir) meets goals in CMV

Japan’s largest rugmaker Takeda Pharmaceutical (TYO: 4502) on Friday announced positive top-line results from the Phase III clinical trial evaluating the efficacy and safety of the investigational drug TAK-620 (maribavir), in the treatment of transplant recipients with refractory/resistant cytomegalovirus (CMV) infection.

The TAK-620-303 (SOLSTICE) trial (NCT02931539) is a multicenter, randomized, open-label, active-controlled trial comparing eight weeks of treatment with either maribavir or investigator assigned treatment (IAT) in transplant recipients with CMV infection refractory or resistant to existing antiviral treatments (ie, one or a combination of ganciclovir, valganciclovir, foscarnet or cidofovir).

Maribavir was originally developed by ViroPharma, but rights to the investigational drug were acquired for $4.2 billion in 2013 by Shire, the $62 billion acquisition of which Takeda completed in January last year. Analytics firm GlobalData has previously projected global sales for TAK-620 to exceed $7 million by 2027, accounting for 3.2% of the overall CMV therapeutics market.