Hopledo has been approved in the EU for adults with Parkinson’s disease who experience motor fluctuations despite medication.
The European Commission decision follows a positive recommendation from the Committee for Medicinal Products for Human Use, the European Medicines Agency committee responsible for assessing medicines seeking EU approval.
Hopledo, also known as IPX203, is an extended-release formulation of levodopa and carbidopa. It is sold in the US under the brand name Crexont.
The oral treatment combines immediate-release granules with extended-release beads in one capsule, allowing treatment to begin working relatively quickly while extending its duration of effect.
Levodopa provides the brain with a precursor that nerve cells can use to make dopamine, helping address the loss of dopamine-producing nerve cells associated with Parkinson’s. Carbidopa helps more levodopa reach the brain.
People taking levodopa can develop motor fluctuations over time, including off periods when symptoms return between doses and dyskinesia, which involves involuntary movements.
Günter Höglinger, director of the department of neurology at LMU University Hospital Munich, said: “A major therapeutic challenge in Parkinson’s disease is maintaining stable motor control throughout the day.
“many patients experience fluctuations in symptom control and often have to plan their daily activities around the timing and duration of levodopa’s effect.
“This combination of extended benefit and reduced dosing frequency represents an important advancement in levodopa therapy in [people with Parkinson’s] and motor fluctuations.”
The EU approval was supported by results from the Phase 3 RISE-PD trial comparing Hopledo with immediate-release levodopa and carbidopa.
The trial found Hopledo significantly increased good on time, when Parkinson’s symptoms are adequately controlled with medication, and reduced off time.
Participants taking Hopledo received an average of three doses each day, compared with five among those receiving the immediate-release formulation.
Findings from a nine-month extension study also indicated sustained symptom control and stable dosing frequency over the longer term.
Zambon Biotech holds exclusive rights to commercialise Hopledo in the EU, UK and Switzerland and plans to begin introducing the treatment in European markets in October.
Giovanni Magnaghi, chief executive of Zambon, said: “For people living with Parkinson’s disease, as well as their caregivers and healthcare professionals, the need for additional therapeutic options to help manage motor fluctuations remains significant.”
“The approval of Hopledo marks an important step in Zambon’s long-standing commitment to the Parkinson’s disease community.”
Josefa Domingos, president of Parkinson’s Europe, said new treatment options can give “people with Parkinson’s and their clinicians more ways to tailor treatment to individual lives.”
She added that the organisation “will keep advocating for timely and equitable access across Europe, so that everyone who could benefit is able to.”
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