FDA approves Newron's
drug as add-on therapy for Parkinson's
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[March 22, 2017]
(Reuters) - 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.
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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)
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