FDAnews

BOEHRINGER INGELHEIM'S RLS DRUG GETS EC APPROVAL

Germany's Boehringer Ingelheim has reported that the European Commission (EC) has approved its Sifrol/Mirapexin (pramipexole) for the treatment of moderate-to-severe restless legs syndrome (RLS) in the EU. Pramipexole has been shown to provide clinically significant relief from the broad range of symptoms associated with RLS, and is the first medication to be approved throughout the EU for this indication.

Until now, there have been limited treatment options available to alleviate the symptoms of RLS, which can significantly impact patients' quality of life. Therefore, this announcement is expected to bring new hope to the millions of people throughout Europe who are affected by this debilitating condition.

"Restless legs syndrome is a surprisingly common, but underdiagnosed condition, that adversely affects the lives of millions of people worldwide," said Claudia Trenkwalder, a professor at the University of Goettingen and the head of the Paracelsus-Elena-Klinik, in Kassel, Germany. "The approval of pramipexole 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, helping them to enjoy their everyday life."

Boehringer Ingelheim had also filed a supplementary new drug application with the US Food and Drug Administration (FDA) seeking an expansion of pramipexole's US label to include treating RLS.

A recent study of pramipexole, which included more than 1,000 patients in Europe and the U.S., confirmed that the drug provides rapid relief from RLS symptoms after just one week of treatment. The drug was well-tolerated and highly efficacious at the starting dose of .125 mg per day, Boehringer Ingelheim reported.