- The NDA is based on P-III TAK-620-303 (SOLSTICE) trial assessing Maribavir vs IAT in HCT and SOT recipients with CMV infection refractory, with/ out resistance, to one or a combination of the conventional antiviral therapies
- Patients underwent a 2wks. screening period, followed by randomization (2:1) to maribavir (400 mg) or IAT for an 8wks. treatment period with 12wks. of follow-up. The study met its 1EPs of superiority
- Maribavir is an orally bioavailable anti-CMV compound, currently in P-III and received the US FDA’s BTD for the same indication. Maribavir is Takeda’s fourth new molecular entity accepted for regulatory review in 6mos.
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