Shots:

• The US FDA’s AMDAC voted to recommend the use of maribavir (TAK-620) to treat refractory CMV infection and disease with/out genotypic resistance to ganciclovir- valganciclovir- foscarnet- or cidofovir in transplant recipients
• The recommendations were based on the results from the P-II & III TAK-620-303 (SOLSTICE) trials of maribavir while the NDA submission of maribavir is based on the P-III TAK-620-303 (SOLSTICE) trial & is currently under the US FDA’s priority review
• Maribavir has received EC’s OD designation for CMV in patients with impaired cell-mediated immunity and US FDA’s ODD for CMV viremia & at-risk patients

Ref: Takeda | Image: Takeda