Xadago To Be Launched in Germany for Parkinson’s Disease

Italian pharmaceutical company Zambon S.p.A. and Newron Pharmaceuticals S.p.A. have announced plans to launch Xadago, a drug therapy for mid- to late-stage Parkinson’s disease, in Germany. The release of the treatment is the result of a partnership between the two companies, and Germany will become the first country to commercialize the drug.

“The launch of Xadago in Germany represents a significant milestone in Zambon’s pharmaceutical business and in particular our increased commitment to R&D innovation,” said the CEO of Zambon, Maurizio Castorina. “The launch of Xadago® is a major step forward in the treatment of Parkinson’s disease, and Zambon is fully committed to invest further for the benefit of all Parkinson’s disease patients.”

Xadago had already received approval for the treatment of patients with Parkinson’s disease as add-on therapy with a stable dose of levodopa (L-dopa) alone or combined with other drugs designed for the condition. The new chemical compound safinamide works with a unique mechanism that selectively and reversibly inhibits MAO-B, while it blocks voltage dependent sodium channels, correcting the deficient modulation of glutamate release.

“When a Parkinson’s disease patient is no longer optimally controlled with levodopa, Xadago® may become the first choice as add-on to levodopa, because it has shown a balanced control of motor symptoms and motor complications. These benefits have been proved at six months and maintained over two years. The reason why is its unique mechanism of action, dopaminergic and non-dopaminergic targets,” explained the chair of the Neurology Department at the University of Dresden, Heinz Reichman. “Xadago® uniquely combines the modulation of the dopamine and glutamate systems, which in add-on therapy may maximize motor symptom control in Parkinson’s disease without worsening motor complications. In due course, most Parkinson’s disease patients worldwide could benefit from the advantages of Xadago.”

Previous studies demonstrated the therapy’s efficacy in the control of both motor symptoms and short-term complications associated to Parkinson’s disease, as well as the management of the drug’s effects for more than two years. Safinamide has been proven safe and effective in reducing motor fluctuations without raising the risk of troublesome dyskinesia, which may be related to the compound’s dual mechanism of action.

“We are pleased that patients with Parkinson’s disease in Germany now have access to a much needed innovative add-on treatment option. Xadago® has shown meaningful improvements in ‘ON and OFF time,’ without any increase in symptoms such as dyskinesia,” added the CEO of Newron, Stefan Weber. “As Newron and partner Zambon continue to pursue additional marketing authorizations, we look forward to seeing access of Xadago® expanded to patients in other regions in Europe and the U.S.”

The CEO announced the future plans of the companies regarding Xadago, which was already accepted for filing by the U.S. Food and Drug Administration. The therapy will be commercialized as the result of a partnership between Zambon, which holds the global rights to develop and commercialize it (except in Japan), and Newron. The companies are now also expecting a final decision from Swissmedic as well.