Boehringer Ingelheim gets EU approval for first RSL treatment

The European Commission has approved Boehringer Ingelheim's Sifrol/Mirapexin (pramipexole) for the treatment of moderate to severe Restless Legs Syndrome (RLS) in the European Union (EU).

RLS is a neurological disorder that produces an uncontrollable urge to move the legs, usually accompanied by unpleasant and sometimes painful sensations in the legs. It affects up to 10% of the population worldwide aged between 30 and 79 years and around one-third of sufferers experience symptoms more than twice weekly.

Pramipexole has been shown to provide clinically significant relief from the symptoms associated with RLS and is the first medication to be approved throughout the EU for this indication.

Professor Claudia Trenkwalder, MD, University of Goettingen and head of the Paracelsus-Elena-Klinik, Kassel, Germany, said: "RSL is a surprisingly common, but underdiagnosed condition, that adversely affects the lives of millions of people worldwide. Not only the physical symptoms, such as the uncontrollable urge to move the legs, but also the emotional symptoms of RLS can profoundly impact the patient's quality of life." He added that patients with this condition will now be able to benefit from effective and well-tolerated relief from a broad range of RLS symptoms.

The German drug-maker has also filed a supplementary new drug application with the US Food and Drug Administration seeking an expansion of pramipexole's US label to include treating RLS.