Zambon And Amneal's Hopledo Receives Positive CHMP Opinion For Parkinson's Disease, European Launch Expected From October 2026
Amneal Pharmaceuticals, Inc. Class A
Amneal Pharmaceuticals, Inc. Class A AMRX | 0.00 |
- Positive CHMP opinion is based on data from the Phase 3 RISE-PD trial, which demonstrated significantly more "Good ON" time with fewer daily doses compared with immediate-release levodopa/carbidopa
- Hopledo® is already approved and marketed in the United States as CREXONT®, providing established regulatory and commercial experience as the therapy advances toward European approval
- More than one million people are living with Parkinson’s disease in the European Union, and over 80% experience motor fluctuations during the course of their disease, highlighting the need for additional treatment options
- Hopledo® contains a unique formulation combining immediate-release granules and extended-release pellets, providing both a rapid onset of action and a longer duration of effect, sustaining the levodopa therapeutic effect for a longer period of time
- If approved, Zambon expects to make Hopledo® progressively available to patients with Parkinson’s disease across Europe starting October 2026