Kyowa Kirin's Nourianz Given the Green Light by FDA for Parkinson's Disease
The U.S. Food and Drug Administration (FDA) gave Kyowa Kirin’s Nourianz (istradefylline) the thumbs-up as an add-on treatment to levodopa/carbidopa in adults with Parkinson’s disease (PD) who experience “OFF” episodes.
“OFF” episodes are a period when PD patient’s medications don’t work well, resulting in increased PD symptoms, such as tremor and difficulty walking.
Levodopa is the standard-of-care for Parkinson’s disease. However, for many patients, levodopa begins to wear off more quickly, which triggers what is called a medication “on-off phenomenon.” What this means is that if you take the drug on a regular basis, you won’t notice a difference in symptoms between doses. But once the on-off phenomenon begins, the ON period is when the drug seems to be working, but the OFF period is when it doesn’t work as well or at all. In these cases, the ON states become shorter and the OFF state occurs earlier.
The approval was based on four 12-week placebo-controlled clinical trials that included 1,143 patients. In all four studies, the patients receiving Nourianz had a statistically significant decrease from baseline in daily “OFF” time compared to the patient administered a placebo.
The most common adverse reactions in people taking the drug were involuntary muscle movement, dizziness, constipation, nausea, hallucination and sleepiness. The FDA indicates patients receiving Nourianz should be monitored for signs of dyskinesia (the involuntary muscle movement) or the worsening of existing dyskinesia.
Nourianz is a selective adenosine A2A receptor antagonist. This approval makes Nourianz the first and only adenosine A2A receptor antagonist indicated for Parkinson’s in the U.S.
“We are proud that Nourianz is now ready to help adult patients with Parkinson’s disease in the U.S.,” stated Tomohiro Sudo, head of Global Product Management Office of Kyowa Kirin. “We believe that Nourianz could be an important contributor to improve treatment outcomes. We will be working to bring the product to patients globally.”
Parkinson’s disease is the second-most common neurodegenerative disorder in the United States, according to the National Institutes of Health (NIH). The first is Alzheimer’s disease. Each year, about 50,000 people in the U.S. are diagnosed with PD and about one million people in the country have it. It is most common in people over the age of 60, although it does occur earlier in some people.
Parkinson’s occurs when certain brain cells, which generate dopamine, become impaired or die. Dopamine helps transmit signals between the parts of the brain that cause smooth, purposeful movements, like eating, writing and shaving.
“Today’s approval is the culmination of decades of perseverance in exploring the science and clinical effects of istradefylline and inhibition of adenosine A2A receptor signaling in people with Parkinson’s disease,” said Jeffrey S. Humphrey, Kyowa Kirin’s chief development officer. “In clinical studies, istradefylline, used as adjunctive treatment to levodopa/carbidopa in adult patients with PD experiencing “OFF” episodes, was associated with a decrease in OFF Time and increase in ON Time without troublesome dyskinesia. We are grateful for the FDA approval and for the many dedicated scientists and patients whose participation in our research programs has resulted in a new treatment option for Parkinson’s disease.”