Italy-based biopharma Newron Pharmaceuticals S.p.A. and its partner, international pharmaceutical company Zambon S.p.A., both dedicated to finding treatments for diseases of the central nervous system (CNS), recently announced their acknowledgement and support of World Parkinson’s Disease Awareness Day, which was on April 11.
Additionally, both companies emphasized their commitment to the ongoing approvals and subsequent launches of Xadago (safinamide) for treating Parkinson’s disease (PD) in Europe, the United States, Japan and certain other Asian countries, through Newron’s partner, Meiji Seika.
Xadago is already available as an add-on therapy to levodopa (L-dopa) exclusively or in combination with other available Parkinson’s therapies for mid-to-long stage unstable patients, in Switzerland, Germany, Spain, Italy, and Belgium.
“Our efforts in bringing to patients with PD an innovative treatment like Xadago are being rewarded by the positive feedback that we have received from clinicians and patients in the countries where we have launched to date. We look forward making Xadago available to more patients in need of a new therapeutic option,” said Maurizio Castorina, Zambon’s CEO, in a press release.
Parkinson’s disease is second in the list of most frequent chronic progressive neurodegenerative disorders in older people, after Alzheimer’s disease. It affects from 1 to 2 percent of people older than 65 worldwide. As Parkinson’s progresses further, symptoms worsen. Early-stage patients can more easily manage their symptoms with L-dopa, which remains the most effective Parkinson’s treatment available to date, with more than 75 percent of PD patients receiving the drug.
But L-dopa has been shown to lead to severely debilitating motor fluctuations when taken for long periods of time, and many patients have reported experiencing involuntary movements, known as L-dopa-induced dyskinesia (LID). Most therapies available today target the dopaminergic system – which is implicated in Parkinson’s pathogenesis – and the majority of these treatments increase dopaminergic transmission, leading to improvement of motor symptoms.
“With an estimated 6.3 million people with Parkinson’s disease worldwide, it is truly rewarding to have developed the first New Chemical Entity (NCE) in 10 years to receive a Marketing Authorization from the EU Commission for the treatment of Parkinson’s disease,” said Newron CEO Stefan Weber. “We look forward to patients around the world with Parkinson’s disease having access to this important therapeutic option.”
Results from 24-month, double-blind, controlled clinical trials suggest that Xadago shows significant improvements on motor fluctuations (ON/OFF time) without increasing the risk of developing LID. This positive outcome might be due to its dual mechanism of action affecting both the dopaminergic and the glutamatergic pathways, according to the studies. Safinamide has been shown to be well-tolerated and easy to use.
“The EPDA welcomes the work being done by Newron and others in bringing new treatments to improve the lives of people with Parkinson’s disease and their families,” said Lizzie Graham, executive director of the European Parkinson’s Disease Association.