AbbVie said on Monday that the Food and Drug Administration 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, which is characterized by reduced levels of the hormone dopamine in the brain, which leads to poor mobility, slowness and stiffness, according to the Parkinson’s Disease Foundation.
Duopa was approved as an orphan drug, giving North Chicago, Ill.-based AbbVie, the biopharmaceutical spinoff of Abbott Laboratories, seven years of market exclusivity. Orphan drugs treat rare diseases and are usually approved with various incentives for the drugmaker.
“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.”