– Norgine B.V. today announced marketing authorisation for PLENVUR for bowel cleansing in adults prior to any procedure requiring a clean bowel has been granted by the Austrian, French, Irish, Italian and Portuguese regulatory authorities. The approval was granted under the European decentralised procedure, with the UK as reference state. PLENVUR has also been approved in Australia. Norgine anticipates launches in these countries in 2018.
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PLENVUR is now approved for use in Austria, Australia, Belgium, Denmark, Finland, France, Iceland, Ireland, Italy, Portugal, The Netherlands and in the UK (known as PLEINVUE™ in Austria and Netherlands). PLENVUR is available in the UK.
PLENVUR is a novel, low volume (1-litre) polyethylene glycol (PEG) 3350-based bowel preparation that has been developed by Norgine to provide whole bowel cleansing.
PLENVUR provides superior high-quality bowel cleansing efficacy (in at least one segment of the colon) compared to two widely used alternative bowel preparations: sodium picosulfate and magnesium salt solution (CITRAFLEETR) and 2-litre PEG with ascorbate (MOVIPREPR).
The approvals were based on data from the Phase III clinical trial programme, consisting of three multicentre, randomised, parallel group studies: MORA, NOCT and DAYB studies.
PLENVUR (NER1006) demonstrated an acceptable safety profile in the NOCT, MORA, and DAYB phase III studies.
Colonoscopy is a vital screening procedure to detect lesions. Colorectal cancer is the second most common cause of cancer-related mortality in Europe, with 447,000 new diagnoses every year.
Norgine manufactures PLENVUR and commercialises the product through its infrastructure in Europe and Australia and through its commercial partners in the rest of the world.
Visualisation of the ascending colon is important because adenomas and polyps in this area are often more difficult to see than those in other areas of the colon.
Access the full media release onwww.norgine.com/media
Media Contact: Isabelle Jouin T: +44-(0)1895-453-643 Follow us @norgine
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