FDA approves Xadago for Parkinson’s patients

Xadago (safinamide) is first NCE approved in the USA for PD patients with motor fluctuations in a decade

The FDA has approved the use of Xadago (safinamide) for the treatment of Parkinson’s disease as add-on therapy to levodopa/carbidopa.

Xadago was developed by Newron Pharmaceuticals and its partners Zambon and US WorldMeds.

Newron Pharmaceuticals is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain.

US WorldMeds is a specialty pharmaceutical company dedicated to developing, licensing and commercializing unique and significant specialty pharmaceuticals that address unmet medical needs or overcome limitations of existing products.

This first new treatment for a decade represents an important addition to the treatment choices for patients.

Zambon is an Italian, multinational pharmaceutical and fine-chemical company established in three therapeutic areas: respiratory, pain and women’s care.

Ravi Anand, Newron’s CMO, said: “Xadago significantly improves ON time, OFF time and Parkinsonism compared to standard of care – without increasing time spent with troublesome dyskinesia in patients experiencing motor fluctuations while on optimised levodopa/carbidopa therapy.”

“Additionally, the onset of improvement of motor fluctuations occurred early in treatment.”

Charlotte Keywood, Global Head of Research and Development at Zambon, said: "This first new treatment for a decade represents an important addition to the treatment choices for patients with Parkinson's.”

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