Approved Parkinson’s treatment wins OK in EU, to be sold as Hopledo
Long-lasting therapy shown in trial to increase good on-time in adults
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- Hopledo, sold in the U.S. as Crexont, is now approved in the European Union for adults with Parkinson's who have motor fluctuations despite treatment.
- The oral therapy is expected to be introduced in European markets in October.
- Hopledo combines immediate-release granules and extended-release beads to increase good on time with fewer daily doses.
Hopledo (IPX203), an extended-release formulation of levodopa and carbidopa sold as Crexont in the U.S., has now won approval in the European Union as a treatment for adults with Parkinson’s disease who experience motor fluctuations despite medications.
The decision, by the European Commission, was based in large part on trial data showing use of the oral therapy led to a significant increase in good on time — when symptoms are well controlled — compared with immediate-release drugs. Hopledo also required fewer daily doses.
The approval follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP), the European Medicines Agency’s committee that’s responsible for evaluating medicines seeking approval in the EU.
Zambon Biotech, which holds exclusive rights to commercialize Hopledo in the EU, the U.K., and Switzerland, plans to begin introducing the newly approved therapy in European markets in October, according to a company press release.
“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,” said Giovanni Magnaghi, Zambon’s CEO. “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, also welcomed the decision, noting that new treatment options can give “people with Parkinson’s and their clinicians more ways to tailor treatment to individual lives.” She added that the umbrella organization, which unites advocacy groups in the EU, “will keep advocating for timely and equitable access across Europe, so that everyone who could benefit is able to.”
Hopledo approved in US under brand name Crexont
A progressive disease, Parkinson’s is caused by the loss of dopamine-producing nerve cells. Dopamine is a signaling molecule that plays an important role in controlling movement, and its loss contributes to the disease’s motor symptoms.
Levodopa is one of the main treatments for Parkinson’s. It provides the brain with a precursor that nerve cells can use to make dopamine, and is commonly combined with carbidopa, which helps more levodopa reach the brain.
Over time, however, people on levodopa may experience fluctuations in how well the medication controls their symptoms. This can include off episodes, or times between treatments when symptoms return, as well as dyskinesia, or involuntary, uncontrolled movements.
“A major therapeutic challenge in Parkinson’s disease is maintaining stable motor control throughout the day,” said Günter Höglinger, MD, director of the department of neurology at LMU University Hospital Munich. “
According to Höglinger, “many patients experience fluctuations in symptom control and often have to plan their daily activities around the timing and duration of levodopa’s effect.”
[The] combination of extended benefit and reduced dosing frequency [with Hopledo] represents an important advancement in levodopa therapy in [people with Parkinson’s] and motor fluctuations.
Hopledo was developed to address these fluctuations by changing how levodopa and carbidopa are released in the body. The oral formulation contains both immediate-release granules and extended-release beads in a single capsule, allowing treatment to begin working relatively quickly while extending its duration of effect.
The drug’s approval in the EU was supported by findings from the Phase 3 RISE-PD trial (NCT03670953). Those results showed that, compared with immediate-release levodopa/carbidopa, Hopledo increased good on time, or periods when Parkinson’s symptoms are adequately controlled with medication, while also reducing off time.
These benefits were achieved with fewer daily doses: Participants taking Hopledo received an average of three doses per day, compared with five doses among those taking the immediate-release formulation.
Long-term findings from a nine-month extension study further indicated that Hopledo was associated with sustained symptom control and a stable dosing frequency.
“This combination of extended benefit and reduced dosing frequency represents an important advancement in levodopa therapy in [people with Parkinson’s] and motor fluctuations,” Höglinger said.
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