Belgium's UCB aims to submit a China FDA application as early as this year following Phase III trials of Neupro (rotigotine) in Chinese patients with early-stage Parkinson's disease, eyeing an extension of a drug already approved for treatments in developed markets.
The company said in a June 16 press release that the clinical trial showed rotigotine significantly improved activities of daily living and motor function compared with a placebo. It presented the data at the 19th International Congress of Parkinson's Disease and Movement Disorders (MDS) in San Diego, held June 14-18, 2015.
But top-line results were announced in February.
The U.S. FDA has already approved a formulation of Neupro in 2012 to treat signs and symptoms of advanced-stage idiopathic Parkinson's disease and the dopamine D2 receptor agonist is approved in the EU to treat signs and symptoms of early stage idiopathic Parkinson's disease as well as in Japan.
- here's the UCB release