AMSTERDAM, November 28, 2017 /PRNewswire/ --
- PLENVU® is the first 1-litre PEG bowel preparation[i],[ii],[iii]
- PLENVU® is superior to MOVIPREP® in providing high-quality cleansing in the colon ascendens - an important area for adenoma detection[iv]
Norgine B.V. today announced that The Medicines Evaluation Board (MEB) in the Netherlands has granted marketing authorisation for PLEINVUE™ for bowel cleansing in adults prior to any procedure requiring a clean bowel. The approval was granted under the European decentralised procedure, with the UK as reference state. Norgine anticipates further marketing approvals in Q4 2017 and 2018.
PLENVU® (known as PLEINVUE™ in the Netherlands), is approved for use in Belgium, Denmark, Finland, Iceland, the Netherlands and in the UK. PLENVU® is available in the UK.
PLENVU® 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.
PLENVU® 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 (CITRAFLEET®) and 2-litre PEG with ascorbate (MOVIPREP®).[v]
The approval was based on data from the Phase III clinical trial programme, consisting of three multicentre, randomised, parallel group studies NOCT, MORA, and DAYB.
Norgine manufactures PLENVU® and commercialises the product through its infrastructure in Europe and Australia and through its commercial partners in the rest of the world.
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i. Bisschops R, et al. P0179. Efficacy and safety of the novel 1L PEG and ascorbate bowel preparation NER1006 versus standard 2L PEG with ascorbate in overnight or morning split-dosing administration: results from the phase 3 study MORA. UEG Journal 2016; 4(5S): A218 - A219.
ii. DeMicco MP Clayton LB, Pilot J et al. Novel 1 L polyethylene glycol-based bowel preparation NER1006 for overall and right-sided colon cleansing: a randomized controlled phase 3 trial versus trisulfate. Gastroentest Endosc 2017; Aug 10. pii: S0016-5107(17)32172-7. doi: 10.1016/j.gie.2017.07.047. [Epub ahead of print].
iii. Schreiber, et al. P1266. Efficacy and safety of the novel 1L PEG and ascorbate bowel preparation NER1006 versus sodium picosulfate + magnesium citrate in day before split dosing administration: results from the phase 3 Study DAYB. UEG Journal 2016; 4(5S): A589-A590
iv. Lasisi F, et al. Expert Rev Gastroenterol Hepatol 2011; 5(6): 745-754.
v. Hassan C, Manning J, Amlani B, Epstein M. High Quality Colon Cleansing With Novel 1L PEG-Based Bowel Preparation NER1006 versus Current Alternatives: Post hoc Analysis of 1,521 Patients in 3 Randomized Phase 3 Trials. P1041. Presented at World Congress of Gastroenterology at the American College of Gastroenterology (ACG) in Orlando, Florida, USA, 13-16 October, 2017
Media contact: Isabelle Jouin, T: +44(0)1895-453643
SOURCE Norgine B.V.