EU OK’s Boehringer’s Mirapex for RLS

Boehringer Ingelheim said Friday the European Commission approved Mirapex for the treatment of restless legs syndrome.

Mirapex, which is also approved for the treatment of Parkinson’s disease, is sold under the trade names Sifrol and Mirapexin in Europe.

Boehringer said it has also filed a supplementary new drug application with the Food and Drug Administration seeking an RLS indication for Mirapex in the United States.

Restless Legs Syndrome is a surprisingly common, but underdiagnosed condition, that adversely affects the lives of millions of people worldwide, Claudia Trenkwalder of the University of Goettingen said in a statement issued by Boehringer. The approval of pramipexole (Mirapex) in Europe means patients with this condition will now be able to benefit from effective and well-tolerated relief from a broad range of RLS symptoms.

The European approval was supported by a study that included more than 1,000 patients in Europe and the United States.

These study results have confirmed that pramipexole (Mirapex) provides rapid relief from symptoms after just one week of starting treatment, Boehringer said.