Boehringer Ingelheim has moved a step closer to extending the uses of its Parkinson’s disease product pramipexole in the European Union to include restless legs syndrome, a neurological condition that affects millions of people around the world.
The EU’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for the product in moderate-to-severe RLS, recommending the application for approval by the European Medicines Agency (EMEA).
Pramipexole is sold in Europe for Parkinson’s disease under the Sifrol and Mirapexin brand names, and Boehringer Ingelheim hopes to win full approval for the drug in RLS in the second quarter of this year.
In RLS, pramipexole is going head to head to with another drug in the dopamine agonist class, GlaxoSmithKline’s ReQuip (ropinirole), which was recommended for approval in Europe in September 2005 and launched for that indication in the USA the previous June. Boehringer Ingelheim has also filed for US approval of pramipexole in RLS.
In Europe, Spain and the Netherlands raised concerns over the safety and efficacy for ReQuip in RLS, though it was approved in France - as Adartrel - in December 2004.
Meanwhile, in coming years competition in the RLS sector could be intense. Schwarz Pharma and Otsuka are working on transdermal rotigotine for RLS in Phase III, and Newron has another candidate – safinamide – in Phase II trials. Meanwhile, other contenders include XenoPort’s XP 13512 (Phase II) and GSK’s radafaxine (Phase II).