Germany’s Schwarz Pharma says that the European Commission has given marketing authorisation for Neupro, its patch-delivered treatment, to be used for all stages of Parkinson's disease.
Neupro (rotigotine), a dopamine receptor agonist, was first approved in March last year for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease as monotherapy (ie without levodopa) or in combination with the latter, through to late stages when the effect of levodopa wears off or when fluctuations of the therapeutic effect occur (end of dose or "on-off" fluctuations). Now it has received the green light to market the patch for advanced stages of the disease.
Neupro has already been launched in Germany, the UK, Austria, Denmark, Ireland, Norway, Switzerland, Sweden, Greece and Spain, though it is still in negotiations with regulators in France to get the treatment onto the market there. However the path to approval is running more slowly in the USA as the Food and Drug Administration sent an approvable letter for Neupro last March asking for more data, but confirmed that the request could be met via additional analyses from the existing database.
The company, which is set to become part of Belgium's UCB in a 4.4 billion euros deal that is due to close shortly, has said that sales of the drug could reach as much as 350 million euros annually, but this figure could be boosted by an additional 300 million euros per year if it is also successful in developing the compound for restless legs syndrome.