Takeda Receives the US FDA Advisory Committee’s Recommendation for TAK-620 (maribavir) to Treat CMV Infection in Post-Transplant Recipients

October 8, 2021 Auto Bot FDA, regulatory, Takeda 0

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

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