March 21 (Reuters) - Newron Pharmaceuticals SpA NWRN.S
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 parnter Zambon SpA in several countries
including Germany, Italy Spaion and UK. urn:newsml:reuters.com:*:nBw4bwptza
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. urn:newsml:reuters.com:*:nL8N1AC1XN
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)
((Akankshita.Mukhopadhyay@thomsonreuters.com; within U.S. +1
646 223 8780, outside U.S. +91 80 6749 0010; ; Reuters
Messaging:
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Keywords: NEWRON FDA/