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CHMP gives positive opinion for Hopledo® to treat Parkinson's motor fluctuations in Europe

Market News
29 Jun 2026
GlobeNewsWire
View Source
Bullish
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The European CHMP has recommended approval of Hopledo® (IPX203), a modified-release levodopa/carbidopa treatment for adults with Parkinson’s disease experiencing moderate to severe motor fluctuations. Based on Phase 3 RISE-PD trial data, Hopledo® showed significantly more 'Good ON' time with fewer daily doses compared to immediate-release levodopa/carbidopa, offering a new option for patients inadequately managed by current therapies. Already approved in the U.S. as CREXONT®, Hopledo® combines immediate and extended-release formulations to provide rapid and sustained symptom control. If approved by the European Commission, Zambon plans to launch Hopledo® across Europe starting October 2026, addressing a significant unmet need for over one million Parkinson’s patients in the EU.

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