Zambon S.p.A., an international pharmaceutical company strongly committed to the Central Nervous System (CNS) therapeutic area, and its partner Newron Pharmaceuticals S.p.A. ("Newron"), a research and development company focused on novel CNS and pain therapies, announced today that the European Commission approved the use of Xadago (safinamide) for the treatment of idiopathic Parkinson's disease (PD). Xadago has been approved for mid-to late-stage fluctuating patients as add-on therapy to a stable dose of Levodopa (L-dopa) alone or in combination with other PD medicinal products. The decision follows the Positive Opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) on December 18th, 2014 and is applicable to all 28 European Union member countries, as well as Iceland, Liechtenstein and Norway.
"Levodopa, still the gold standard of symptomatic efficacy in the treatment of Parkinson's disease, in its long-term use is associated with motor complications which still constitute a major unmet medical need in PD therapy - stated Prof. Werner Poewe, Director of the Department of Neurology, Innsbruck Medical University and University Hospital. "Targeting non-dopaminergic systems might be an alternative approach to improve and control such motor complications, enhancing efficacy and removing the need for further increases in levodopa dose, that has been shown to worsen motor fluctuations."
Ravi Anand, Newron's CMO, commented: "We're extremely pleased to see the European Commission's approval, providing a next generation, innovative add-on treatment option to PD patients. Xadago (safinamide) is the first add-on treatment for PD showing both rapid onset of efficacy and improvements in 'ON and OFF Time', without any increase in dyskinesia for at least two years, compared with 'Standard of Care', as demonstrated in a double-blind trial in patients receiving optimized treatment for PD. The compound's dual mechanism includes highly selective, reversible inhibition of MAO-B, and state and use-dependent blockade of sodium channels; the latter action leads to inhibition of stimulated release of glutamate. As excessive glutamate release is implicated in the etiology of dyskinesia, Xadago (safinamide) could prevent or attenuate L-dopa induced dyskinesia in PD patients."
"We are particularly proud of this result - said Maurizio Castorina, CEO of Zambon S.p.A. - since it is another acknowledgement of the commitment of Zambon in answering the unmet needs of PD patients. This is the first time in 10 years that a New Chemical Entity (NCE) receives the EC approval for the treatment of PD patients and we are really excited to be a part of it. We will now proceed with the marketing authorizations in the EU countries, starting in the first half of 2015, to give the opportunity to all the patients in need to receive this therapy."