This decision by the Therapeutic Goods Administration of the Australian Government Department of Health adds Australia to the list of countries in which Xadago is approved as an add-on treatment for Parkinson’s, including Switzerland, 13 EU countries, and the U.S., where the compound became available in July 2017.
The announcement was made by Zambon, the pharmaceutical company commercializing the therapy, and its partner, Newron Pharmaceuticals, which developed the therapy. Both companies focus on the development of therapies for patients with diseases of the nervous system.
Seqirus, a provider of pharmaceuticals and vaccines in Australia and New Zealand, is also partnering with Zambon to supply the therapy.
Parkinson’s disease is a neurodegenerative disorder for which there currently is no cure. The disease is characterized by the damage or loss of nerve cells within the brain that are responsible for producing the signaling molecule dopamine, a chemical involved in everyday smooth and purposeful movement, such as using a fork to eat, putting on clothes, and walking.
Current therapy with levodopa and/or carbidopa is partially effective, but results in fluctuations between a state of normal motor function (known as “on episodes,” or on-time) and decreased motor function (“off episodes,” or off-time) as the treatment’s effectiveness wears off. In addition, the higher doses required as the disease progresses often result in dyskinesia — uncontrolled involuntary movements.
Xadago works through the selective and reversible inhibition of the enzyme monoamine oxidase B (MAO-B), which increases levels of functional dopamine, and by blocking voltage-dependent sodium channels, which regulates the release of abnormal glutamate, a neurotransmitter in the brain involved in nerve cell communication.
Xadago is an oral, once-a-day, add-on therapy developed to improve motor function in Parkinson’s patients experiencing off episodes. Clinical trials have established its safety and ability to control motor symptoms and complications for more than two years. Results from a 24-month controlled study showed that Xadago had substantial effects on motor fluctuations (on/off time) without increasing the risk for dyskinesia.
“The approval of safinamide in Australia is a great step forward for patients who need new treatment options for Parkinson’s disease,” said Roberto Tascione, CEO of Zambon. “Our partner Seqirus is committed to launch this product and make this innovative therapy available to patients suffering from Parkinson’s disease in Australia.”
Zambon is also currently leading discussions on additional distribution agreements in Europe and the Middle East. Marketing approval and commercialization of Xadago has been filed in Japan and is under review in Brazil, Canada, Colombia, and Israel.