UCB Receives CHMP Positive Opinion On Bringing Neupro(R) Back To All Patients In Europe

Main Category: Parkinson's Disease
Also Included In: Neurology / Neuroscience
Article Date: 02 Jun 2009 - 5:00 PDT

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UCB announced that the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending that the European Commission lifts the treatment restrictions for Neupro® (rotigotine transdermal patch) in Europe.

"The positive opinion of the EMEA's CHMP is an important step towards making Neupro® available to all patients with Parkinson's disease and to patients with Restless Legs Syndrome" said Troy Cox, Senior Vice President CNS Operations, UCB. "UCB is proud of its record of providing innovative treatment solutions for conditions that have a real unmet need. With Neupro® we have a 24 hour, continuous drug delivery treatment that offers patients improvements in their symptoms and benefits to their everyday lives."

In June 2008, Neupro® supply in Europe was limited to patients already established on the drug. UCB has fully implemented a cold-chain storage and distribution system and all stocks of Neupro® (2 mg/24 h, 4 mg/24 h, 6 mg/24 h and 8 mg/24 h) have been replaced with product that is refrigerated from manufacturer to patient. Pending final approval of the European Commission, Neupro® will be available to all patients with Parkinson's disease in Europe.

Neupro® in Parkinson's Disease

Parkinson's disease affects approx. three million patients in the seven major markets (U.S., Japan, Germany, UK, France, Italy and Spain). Neupro® provides statistically significant and clinically relevant improvements in movement and ability to carry out everyday activities in people with early stage Parkinson's disease and significantly reduces 'off' time and increases 'on' time in people with later stage Parkinson's disease. Formulated as a once-a-day transdermal patch, Neupro® continuous drug delivery provides stable drug levels in the bloodstream.

Neupro® in RLS

In August 2008, the European Commission approved Neupro® for the symptomatic treatment of idiopathic moderate to severe Restless Legs Syndrome (RLS) in adults. Pending final approval of the European Commission, the UK and Germany will be the first European countries to launch Neupro® (1 mg/24 h, 2 mg/24h and 3 mg/24 h) in this new indication.

RLS affects between three and ten per cent of the population to some extent. In a clinical trial of 458 patients with moderate to severe RLS, Neupro® (1 mg/24 h, 2 mg/24 h and 3 mg/24 h dose) proved more efficacious than placebo in relieving bedtime, night and daytime symptoms in patients over a six month treatment period. Neupro® was shown to reduce symptoms by >=50% in over half of patients (54.2%) compared to symptom reduction in approximately one third (29.9%) of patients on placebo. In addition more patients receiving Neupro® (3 mg/24h) achieved clinical remission (47.3% vs. 22.8% placebo) and symptom freedom (31.3% vs. 12.3% placebo).

About Parkinson's Disease

Parkinson's disease is a chronic, degenerative neurological disease which affects approximately six million people worldwide. Parkinson's disease develops with the loss of nerve cells in the brain which produce a chemical called dopamine. The symptoms of Parkinson's disease develop gradually as levels of dopamine fall and include: tremors (uncontrollable shaking), rigidity (stiffness or tensing of the muscles) and bradykinesia (slowness of movement, and loss of spontaneous movement). Parkinson's disease is often divided into two parts; early stage and later stage disease.

About Restless Legs Syndrome

RLS is a lifelong condition, the symptoms of which may gradually worsen with age. RLS affects between 3 and 10% of the population to some extent, causing sensations such as tingling, burning, tugging, gnawing and pulling, and ranging in severity from uncomfortable to irritating and at times painful. Symptoms frequently occur during periods of rest and inactivity such as night time. If left untreated, Restless Legs Syndrome can cause exhaustion and negatively impact quality of life.

About Neupro® in Europe

Neupro® is indicated in Europe for the symptomatic treatment of moderate to severe idiopathic restless legs syndrome in adults, and for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease, as monotherapy or in combination with levodopa over the course of the disease through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occurs.

Neupro® in the U.S.

UCB recalled Neupro® from the U.S. market in April 2008 after ongoing monitoring revealed that specific batches of Neupro® had deviated from their approved specification. UCB is working with the U.S. Food and Drug Administration (FDA) so that Neupro® can be available to patients with early-stage Parkinson's disease as soon as possible.

Source
UCB