Posted by Michael Wonder on 26 Feb 2025
EMA accepts marketing authorisation application for ND0612, an investigational treatment for motor fluctuations in Parkinson’s disease
21 February 2025 - Mitsubishi Tanabe Pharma today announced the EMA has accepted for review the marketing authorisation application for ND0612, an investigational treatment for motor fluctuations in Parkinson's disease on 20 February 2025 (local time).
The marketing authorisation application is supported by efficacy, safety and tolerability data from the global Phase 3 BouNDless trial of ND0612 compared to oral immediate-release levodopa/carbidopa, as well as long-term safety and tolerability data from the ongoing Phase 2b BeyoND trial of ND0612 beyond one year in people with Parkinson's disease.
