Days after getting an approval in the USA for Cimzia, Belgium’s UCB has now received a recommendation from European regulators for Parkinson’s disease drug Neupro to be marketed as a treatment for restless legs syndrome.

The firm said that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has backed Neupro (rotigotine) for RLS, based on data from two trials that evaluated the efficacy and safety of the drug over a six-month period in almost 1,000 patients with RLS.

RLS affects between 3% and 10% of the population and is characterised by unpleasant feelings in the legs and an irresistible urge to move in order to relieve the discomfort. The exact cause is not known but UCB said that recent clinical research suggests that the disorder is genetically-based.

The news ends a good week for UCB which saw the US Food and Drug Administration approve Cimzia (certolizumab pegol) for adults with moderate to severe Crohn's disease who have not responded to conventional therapies. That news saw the Brussels-headquartered firm’s stock leap 20% and at the group’s annual general meeting yesterday chief executive Roch Doliveux said the firm’s future looks bright.

He acknowledged, however, while UCB had its share of good news of late, “we also had our disappointments”. In particular he referred to the recall of Neupro Parkinson’s patches from the US market and certain batches in Europe. The issue is neither one of efficacy nor safety, Mr Doliveux said, “but of solubility with the active substance crystallising over time in the patch. It is a known phenomenon in the industry that can be resolved by changing formulation”.

He added that “we are working to correct the issue as fast as possible but it might take some time to have Neupro back on the US market”. UCB will need to plug the gap in sales resulting from the loss of patent protection on its biggest earners – the allergy drug Zyrtec (cetirizine) and the antiepileptic Keppra (levetiracetam) – in 2007 and 2009, respectively and Mr Doliveux said that Cimzia, Neupro, plus Vimpat (lacosamide) for epilepsy and diabetic neuropathic pain will help soften the blow.