Primärquellen-Eintrag
WesentlichEMA-Stellungnahme
Zambon/Amneal: positives CHMP-Gutachten für Hopledo (IPX203) bei Parkinson
CHMP adopted a positive opinion recommending EMA marketing authorization for Hopledo (modified-release levodopa/carbidopa) in adults with Parkinson’s disease and moderate to severe motor fluctuations. The opinion is based on the Phase 3 RISE-PD trial showing increased Good ON time with fewer daily doses versus immediate-release levodopa/carbidopa. If approved by the European Commission, Zambon plans phased European launch starting October 2026.
Kernfakten
- Eingereicht
- 29. Juni 2026, 07:00
- Ereignis
- EMA-Stellungnahme
- Richtung
- Positiv
- Unternehmen
AMRXAmneal- Asset
- levodopa/carbidopa
- Quelle
- Unternehmensmitteilung
- Belegstatus
- Belegt
Auszug aus der Quelle
Zambon and Amneal Announce Positive CHMP Opinion for Hopledo® (IPX203) for Adults with Parkinson’s Disease and Moderate to Severe Motor Fluctuations 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 combini