Newron Pharmaceuticals SpA said on Tuesday the U.S. Food and Drug Administration approved its Parkinson's disease treatment Xadago as an add-on therapy to levodopa, a drug widely used to treat the disease.
Levodopa was developed in the late 1960s and is the first-line treatment for the management of Parkinson's, according to the National Parkinson Foundation.
Xadago received European approval in 2015, and has been launched by Newron's partner Zambon SpA in several countries including Germany, Italy Spaion and UK.
The FDA rejected Xadago last year, but later said Newron was not required to perform any studies to evaluate the safety profile of the drug.
Parkinson's disease is the second-most common chronic progressive neurodegenerative disorder in the elderly after Alzheimer's disease. Parkinson's affects an estimated 7-10 million patients worldwide, of whom 1 million are in the United States.
(Reporting by Akankshita Mukhopadhyay in Bengaluru; Editing by Saumyadeb Chakrabarty)