Vyalev, a brand name for AbbVie’s ABBV-951 (foslevodopa/foscarbidopa), is now available in Canada as a continuous, subcutaneous (under-the-skin) infusion treatment for people with advanced Parkinson’s disease and motor symptoms that cannot be well controlled with oral medications.
“AbbVie is proud to deliver the first new treatment for advanced Parkinson’s disease in a decade, [bringing] a much-needed new non-surgical option to patients who seek options when managing their disease,” Rami Fayed, vice president and general manager at AbbVie Canada, said in a company press release.
“This announcement gives hope to people with Parkinson’s that they will have access to more options to help manage their disease even in the advanced stages,” said Karen Lee, PhD, president and CEO of Parkinson Canada, which provides education, support, and advocacy on behalf of people with Parkinson’s.
Motor symptoms can continue on oral levodopa as Parkinson’s progresses
Motor symptoms of Parkinson’s are due to the loss of dopamine, a chemical messenger that transmits information from one nerve cell to another, in an area of the brain responsible for controlling movements. As the disease progresses, symptoms gradually get worse.
Oral levodopa is a building block from which dopamine is formed in the body. It is usually used with carbidopa, which stops the body from breaking down levodopa, so that more is available to form dopamine. Carbidopa also works to reduce the amount of levodopa that needs to be taken, helping to limit its side effects.
Over time, however, levodopa’s benefits begin to diminish within hours of each dose. Patients with advanced disease can experience severe motor fluctuations and dyskinesia (sudden, uncontrolled movements) as the medication’s effects wear off.
“As Parkinson’s progresses, oral treatment options may no longer control symptoms appropriately. Despite this, only a relatively small number of patients consider device-aided therapy, an option that requires surgery,” said Alfonso Fasano, MD, PhD, a neurologist and co-director of the surgical program for movement disorders at Toronto Western Hospital.
Vyalev is designed to deliver a continuous, stable supply of prodrug versions of levodopa and carbidopa, which turn into their active forms once they enter the body. This is expected to reduce off episodes, periods when motor symptoms return between doses.
“This new therapy builds on our remarkable legacy with Duodopa [a gel, marketed as Duopa in the U.S., for continuous delivery of levodopa/carbidopa into the small intestine] and is proof of our longstanding commitment to people living with Parkinson’s disease and their care partners in Canada,” Fayed said.
Health Canada’s decision to approve Vyalev was based on data from a Phase 3 clinical trial (NCT04380142) involving 141 adults with advanced Parkinson’s and poorly controlled motor symptoms despite treatment with oral levodopa/carbidopa.
Patients were randomly assigned to either a continuous subcutaneous infusion of Vyalev plus oral placebo capsules, or to a continuous subcutaneous placebo infusion plus oral levodopa/carbidopa for 12 weeks, or about three months.
Data showed that Vyalev was better than oral levodopa/carbidopa at treating motor fluctuations, with patients on Vyalev experiencing good control of motor symptoms without troublesome dyskinesia for an average of 1.75 hours more each day.
Treatment marketed as Produodopa in the European Union
Its approval also was supported by an open-label Phase 3 clinical trial (NCT03781167) and its ongoing long-term extension (NCT04379050). Data from its 244 patients showed that Vyalev, on average, prolonged on time by more than three hours each day while also reducing the time spent in off episodes.
The Canadian Agency for Drugs and Technologies in Health, which provides independent information for publicly funded healthcare, has recommended Vyalev be reimbursed by public drug plans for patients with unpredictable changes in motor symptoms and severe limitations in daily life activities while on optimized oral treatment.
“There is a high physical and emotional toll not only for the person but also their family and care partners,” Lee said. “No one experiences Parkinson’s the same way, which is why it is critical that people with Parkinson’s have access to options that will help manage their symptoms across all stages of the disease.”
Vyalev also is available in Japan to treat motor symptoms associated with medications wearing off.
In the European Union and the U.K., it is marketed under the brand name Produodopa. In the U.S., regulators have requested additional information about its infusion device before ABBV-951 can be considered for approval.
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