CHICAGO — AbbVie said on Monday that the Food and Drug Administration (FDA) has approved its drug for Parkinson’s disease.
Duopa, which is delivered directly into the small intestine with a portable infusion pump, treats symptoms such as tremors and muscle rigidity. The drug is already approved in Canada and dozens of other countries under the name Duodopa.
About 1 million Americans have Parkinson’s, a disease characterized by reduced levels of dopamine in the brain, which causes slowness, reduced mobility and stiffness, the Parkinson’s Disease Foundation says.
Duopa was approved as an orphan drug, used to treat rare diseases and usually approved with various incentives for the drugmaker.
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“There is unmet need for treatment options for patients with advanced Parkinson’s disease,” said Dr. C. Warren Olanow, lead investigator of the Duopa pivotal trial. “As the disease advances, it can be difficult to control motor features.”
Parkinson’s is characterized by reduced levels of the hormone dopamine in the brain, which leads to poor mobility, slowness and stiffness.