US FDA approves Boehringer Ingelheim's once-daily Mirapex ER for early Parkinson's disease and Gilead's Cayston for cystic fibrosis

The US Food and Drug Administration has approved German independent drug major Boehringer Ingelheim's Mirapex ER (pramipexole dihydrochloride) extended-release tablets, a new once-daily treatment option for the signs and symptoms of early idiopathic Parkinson's disease. The drug is not indicated in advanced PD.

Parkinson's is a chronic, slowly progressive and potentially debilitating neurological condition affecting nearly one million people in the USA, with one person newly diagnosed every nine minutes. Pramipexole, also used in the treatment of restless legs syndrome, generated revue of 752 million euros ($1.02 billion) for the company in 2008, up 21% on the previous year.

"Mirapex for early Parkinson's disease is a positive development in the treatment of this disease. This new, once-daily treatment has a more convenient dosing schedule, offering greater flexibility as someone with early Parkinson's disease plans his or her day," said Robert Hauser, professor of Neurology, and director, Parkinson's Disease & Movement Disorders Center at the University of South Florida College of Medicine, USA. "In general, patients often prefer once-daily dosing to a more frequent regimen because of convenience," he noted.