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

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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

Related post