Approval of Parkinson’s therapy urged in Europe under brand name Hopledo

A European Medicines Agency (EMA) committee is recommending approval of Hopledo (IPX203) — an extended-release formulation of levodopa and carbidopa sold in the U.S. under the brand name Crexont — for people with Parkinson’s disease in the European Union who experience motor fluctuations despite treatment.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) is a regulatory body tasked with reviewing data on experimental medicines under consideration for approval in the EU member nations. While the European Commission, the body that ultimately approves all medications for use in the EU, does not have to abide by the CHMP’s recommendations, it almost always does.

Subject to the commission’s approval, Zambon Biotech — which holds rights to the treatment in Europe — expects to start marketing the Parkinson’s therapy in the EU in October, according to a company press release announcing the committee’s recommendation.

“The CHMP positive opinion represents an important step [toward expanding] access to this important therapy to patients in Europe,” said Mathias Knecht, MD, Zambon’s chief medical officer for innovative therapies.

The treatment has been approved in the U.S. since 2024, where it’s marketed by Amneal Pharmaceuticals. It’s now under review in Canada, also as Crexont, as a treatment to provide steady symptom control for Parkinson’s patients. Zambon holds the exclusive rights to seek the therapy’s approval and commercialization in the EU, the U.K., and Switzerland.

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Parkinson’s is caused by the progressive loss of nerve cells that produce dopamine, a signaling molecule involved in motor control. That loss ultimately drives most disease symptoms.

Levodopa is a mainstay of Parkinson’s treatment that works by giving nerve cells more raw material they can use to produce dopamine. It is commonly given alongside carbidopa, which allows more levodopa to reach the brain. However, its long-term use may lead to off episodes, periods when symptoms aren’t well controlled with the medication, and dyskinesia, or sudden, uncontrolled movements.

Hopledo designed to extend good on time for Parkinson’s patients

Hopledo is a novel levodopa/carbidopa formulation that combines immediate-release granules with extended-release pellets, providing both a rapid onset of action and a longer duration of benefit.

“As the disease progresses, many patients require frequent dosing yet continue to face motor fluctuations. Hopledo addresses this unmet need by providing longer-lasting ‘Good On’ time with fewer daily doses,” Knecht said.

The CHMP’s recommendation was based on data from a Phase 3 clinical trial called RISE-PD (NCT03670953) that showed that Hopledo significantly increased the periods when symptoms were well controlled with medication compared with immediate-release levodopa/carbidopa formulations. The now-completed trial involved more than 600 people with Parkinson’s

The medication’s benefits were achieved with less frequent dosing, specifically an average of three versus five doses per day. Long-term data showed Hopledo remained safe and effective over nine months of treatment, with most side effects mild or moderate, and occurring within the first three months of use.

As [Parkinson’s] disease progresses, many patients require frequent dosing yet continue to face motor fluctuations. Hopledo addresses this unmet need by providing longer-lasting ‘Good On’ time with fewer daily doses.

U.S. marketer Amneal also welcomed the CHMP’s positive recommendation in a separate press release. The company noted that the drug’s ongoing use in the U.S. “[provides] established regulatory and commercial experience as the therapy advances toward European approval.”

Fabrizio Stocchi, MD, PhD, of San Raffaele University in Rome and head of the Parkinson’s Disease Research Centre, noted that, for people with Parkinson’s, “treatment is focused on maintaining consistent symptom control by prolonging levodopa benefit, reducing ‘Off’ time, and simplifying dosing.”

According to Stocchi, “Hopledo … offers a significant advancement in the management of motor symptoms and in achieving more stable and sustained therapeutic effects.”