Takeda Reports the US FDA’s Acceptance and Priority Review of Maribavir’s NDA for Post-Transplant CMV Infection

 Takeda Reports the US FDA’s Acceptance and Priority Review of Maribavir’s NDA for Post-Transplant CMV Infection

Takeda Reports the US FDA’s Acceptance and Priority Review of Maribavir’s NDA for Post-Transplant CMV Infection

Shots:

  • 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.

Click here to­ read full press release/ article | Ref: Takeda | Image: Pharmaceutical Technology

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