RegulatoryJun 29, 2026, 03:01 AM
Amneal/Zambon Hopledo® Gets Positive EU CHMP Opinion
AI Summary
Amneal Pharmaceuticals and Zambon announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending marketing authorization for Hopledo® in Europe. Hopledo®, known as CREXONT® in the U.S., is a novel oral formulation for Parkinson's disease patients experiencing moderate to severe motor fluctuations. This recommendation, based on positive Phase 3 trial data, paves the way for a new treatment option for over one million Parkinson's patients in the EU, with a phased launch expected to begin in October 2026.
Key Highlights
- CHMP adopted a positive opinion for Hopledo® (modified-release levodopa/carbidopa) in Europe.
- Hopledo® is for adult Parkinson's disease patients with moderate to severe motor fluctuations.
- The positive opinion is based on data from the Phase 3 RISE-PD trial.
- Hopledo® is already approved and marketed in the U.S. as CREXONT®.
- Zambon expects to progressively launch Hopledo® across Europe starting October 2026.
- Over 1 million people in the European Union are living with Parkinson's disease.
- This milestone underscores Amneal's continued international growth and strategic opportunity.
Price Impact
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