Takeda Reports P-III Trial (AURORA) Results of Maribavir for Cytomegalovirus Infection in Hematopoietic Stem Cell Transplant Patients
Shots:
- The P-III trial (AURORA) evaluating maribavir vs valganciclovir in 553 HSCT recipients with CMV inf.
- The results showed that patients achieved CMV clearance (69.6% vs 77.4%) @8wk. but failed to meet its 1EPs of non-inferiority based on the prespecified margin of 7%, At 16wk., 52.7% vs 48.5% achieved maintenance effect of viremia clearance & symptom control from 8wk. The sustained maintenance effect was reported during post-treatment evaluations @12wk. (59.3% vs 57.3%) & at 20wk. (43.2% vs. 42.3%), respectively
- The therapy showed a favorable safety profile, treatment-emergent neutropenia (63.5% vs 21.2%), and a high rate of premature treatment discontinuation (17.5% vs 4%). The results will be submitted for publication in a peer-reviewed journal
Ref: Businesswire | Image: Takeda
Click here to read the full press release
Tags
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.