Takeda Receives the US FDA Advisory Committee’s Recommendation for TAK-620 (maribavir) to Treat CMV Infection in Post-Transplant Recipients
Takeda Exercises its Option with Denali to Co-Develop and Co-Commercialize DNL593 (PTV:PGRN) for Frontotemporal Dementia-Granulin
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
Click here to read full press release/ article | Ref: Takeda | Image: Twitter