Italian Pharma Newron and its partner Zambon (from Milan) have been granted a license by Swissmedic (the regulatory agency in Switzerland) for Xadago, a new combo ‘add-on’ therapy for Parkinson’s Disease.
Zambon, is a Pharmaceutical Company with a strong commitment in central nervous system (CNS) diseases. Its partner, Newron Pharmaceuticals, is a research and development biotech from northern Italy which is focused on novel CNS and pain therapies.
Xadago (Safinamide) is the flagship drug in Newron’s pipeline, and is actually 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.
Xadago will be now be used as add-on therapy to levodopa (L-dopa), alone or in combination with other therapies for patients with Parkinson’s disease, who have mid-to late-stage and motor fluctuations. The approval in Switzerland was preceded by the marketing authorization throughout the European Union by the Commission of the EU, in February 2015. Xadago was also accepted for a second review by the US FDA.
Parkinson’s disease is the second most common chronic progressive neurodegenerative disorder in the elderly after Alzheimer’s disease, affecting 1-2% of individuals worldwide aged 65. The prevalence of the PD market is expected to grow in the next years due to the increase in the global population and advancements in healthcare that contribute to an aging population at increased risk for Parkinson’s disease…
This approval by Swissmedic is therefore very good news, and might persuade other regulatory authorities to jump on the Xadago bandwagon (seeing as the US FDA refused it’s passage last July).