The European Commission has granted marketing authorization for Hopledo, an extended-release levodopa-carbidopa capsule already sold in the United States as Crexont, clearing the way for the drug to reach European Parkinson’s patients as soon as next month.
The approval, finalized in early September, follows a positive opinion issued in June by the European Medicines Agency’s Committee for Medicinal Products for Human Use, or CHMP. Milan-based Zambon and New Jersey-based Amneal Pharmaceuticals, which jointly developed the therapy, said they expect a phased rollout across European markets beginning in October.
The drug combines immediate-release granules with extended-release pellets in a single capsule, giving patients a fast onset of symptom relief along with a longer window of benefit than standard immediate-release formulations.
Approval was based on data from the Phase 3 RISE-PD trial, which found patients taking the drug had significantly more “Good On” time, periods when medication is working without troublesome dyskinesia, compared with those on immediate-release carbidopa-levodopa. The trial also showed patients needed fewer doses per day.
The medication was already approved and marketed in the U.S. as Crexont, following FDA clearance in August 2024. That approval came after the agency had rejected an earlier application for the drug, then known as IPX203, in 2023.
Amneal and Zambon entered a licensing agreement in 2024 giving Zambon commercialization rights across the United Kingdom, the European Union and Switzerland.
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