CHMP Backs Italian Firm Newron's Xadago For Parkinson's In EU

Newron Pharmaceuticals, an Italian R&D pharma firm focused on novel CNS and pain treatments, announced together with its partner Zambon that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Xadago (safinamide) for the treatment of mid- to late- stage Parkinson’s disease.

Safinamide is a highly selective and reversible MAO-B inhibitor that works to increase the extracellular levels of dopamine in the striatum. Xadago has the potential to improve the ON time in patients with motor fluctuations who are under L-dopa monotherapy or in combination with other dopamine agonists, such as entacapone, amantadine, and/or anticholinergics. The drug is being developed for the treatment of patients with mid-late stage PD who are experiencing motor fluctuations despite being stabilized on standard of care treatments.

The positive opinion was based on the results of two international Phase 3 placebo-controlled studies involving more than 1,100 patients. The company reports that the drug demonstrated sustained efficacy for over two years compared to standard of care drugs. Xadago also significantly improved motor fluctuations, Parkinsonism, Quality of Life, and Activities of Daily Living without any increase in ON Time related to dyskinesia.

C. Warren Olanow, Professor of Neuroscience at the Mount Sinai School of Medicine, said, “Safinamide's effects are dependent upon pharmacological mechanisms that are not shared with other PD drugs. These effects include its dual mechanism of highly selective, reversible inhibition of MAO-B, and state and use-dependent blockade of sodium channels that inhibit glutamate release, implicated in causing dyskinesia. Preclinical experiments and data from a large number of dyskinetic patients enrolled in a placebo controlled clinical study indicate that safinamide also has the potential to improve L-dopa-induced dyskinesia in PD patients.”

Ravi Anand, Newron's CMO, said, “The CHMP decision on safinamide is a great result for PD patients and physicians, providing them with a therapeutic alternative that is an improvement over "standard of care" in patients with mid-late stage Parkinson's disease patients on L-dopa, who constitute a major proportion (over 75 percent) of those that are experiencing this progressive debilitating disease.”

The drug is the first New Chemical Entity (NCE) to be given a positive recommendation from the CHMP for the treatment of Parkinson’s in a decade. The news buoyed the company’s shares to a six-year high last week. Newron’s partner Zambon said the companies expect to launch the drug in the first half of 2015 once it secures approval from the European Commission.

Other companies targeting the difficult-to-treat disease include NeuroDerm and Pfizer, which advanced their respective candidates into clinical development and nearer to commercialization this year.