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FDA Approves Neurocrine Biosciences' Parkinson's Drug

By Jim Crumly - Updated Jun 24, 2020 at 3:05PM

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The company's second commercial drug will launch later this year.

Neurocrine Biosciences (NBIX 1.82%) announced Monday that the Food and Drug Administration (FDA) has approved Ongentys (opicapone), a daily pill for Parkinson's disease.

Ongentys is an add-on treatment for Parkinson's patients who are currently taking the main first-line treatment, levodopa (L-Dopa), combined with carbidopa to moderate side effects. As the disease progresses, some patients experience more frequent episodes of  motor-function issues between their levodopa treatments. Ongentys is a COMT inhibitor, a drug that blocks the enzyme that breaks down levodopa, therefore prolonging its clinical effects during those "off times."

Pill and a pill bottle.

Image source: Getty Images.

There are currently about 1 million Parkinson's patients in the U.S., with about 70% of them taking levodopa; among that group, 70% take some sort of add-on treatment. Neurocrine's aspiration for Ongentys is for it to become a standard add-on treatment for Parkinson's sufferers when levodopa is no longer adequately controlling their symptoms. The drug was approved in Europe in 2016, and Neurocrine obtained exclusive development and commercialization rights for it in the U.S. and Canada in 2017.

Earlier this month the company said it would delay its commercial launch of Ongentys in the U.S. and Canada until later this year due to the COVID-19 pandemic, which left it unsure about to its ability to get an adequate supply of the drug. Ongentys is Neurocrine's second commercial drug, joining Ingrezza, which helped the biotech deliver 75% revenue growth in 2019, and sent the stock upward by more than 50%.

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