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Kyowa Kirin's add-on therapy for Parkinson's disease approved by US FDA

Kyowa Kirin Co. Ltd.'s drug Nourianz was approved by the U.S. Food and Drug Administration as an add-on treatment for adults with Parkinson's disease.

Parkinson's disease is a condition in which the nervous system becomes progressively damaged, causing tremors, rigidity, slow movement and postural instability.

The drug, also known as istradefylline, was approved as an add-on therapy to levodopa/carbidopa in adult patients with Parkinson's disease experiencing so-called off episodes — times when a patient's medications are not working well and symptoms, such as tremor and difficulty walking, increase.

The effectiveness of Nourianz in Parkinson's disease patients experiencing off episodes was studied in four 12-week clinical studies that included 1,143 participants. In all four studies, Nourianz, administered in tablet form, was shown to decrease daily off time better than placebo.

Parkinson's disease is the second-most common neurodegenerative disorder in the U.S. after Alzheimer's disease, with about 50,000 Americans diagnosed annually. The disorder typically affects people over age 60, but it can occur earlier.

Tokyo-based Kyowa Kirin makes and sells medicines for the therapeutic areas of oncology, nephrology, central nervous system and immunology.