AMSTERDAM, November 6, 2017 /PRNewswire/ --
- PLENVU® is the first 1-litre PEG bowel preparation
- PLENVU® shown to be superior to MOVIPREP® in providing high-quality cleansing in the colon ascendens - an important area for adenoma detection
Norgine B.V. today announced that the Federal agency for medicines and health products and the Danish Medicines Agency have granted marketing authorisation for PLENVU® (NER1006) for bowel cleansing in adults prior to any procedure requiring a clean bowel. The approval was granted under the European Medicines Agency decentralised procedure, with the UK as reference state. Norgine anticipates further marketing approvals in Q4 2017 and 2018.
PLENVU® will be launched in early 2018 in Belgium and Denmark. PLENVU® is already 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, shown to be superior in providing high-quality cleansing in the colon ascendens, an important area for adenoma detection.
The approval was based on data from the Phase III clinical trial programme, consisting of three multicentre, randomised, parallel group studies:
- MORA study. A European study that compared NER1006 versus a 2 litre PEG with ascorbate bowel cleansing solution (MOVIPREP®) using a 2-day split-dosing regimen and a 1-day morning split-dosing regimen in adults. The study met both primary endpoints.
- NOCT study. A US study that compared NER1006 versus a trisulfate bowel cleansing solution using a 2-day split-dosing regimen in adults. Both primary endpoints were met.
- DAYB study. A European study that compared NER1006 versus a sodium picosulfate and magnesium salt solution using a day before split-dosing regimen in adults. The study met both primary endpoints.
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.
 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.
 Lasisi F, et al. Expert Rev Gastroenterol Hepatol 2011; 5(6): 745-754.
Isabelle Jouin, T: +44(0)1895-453643
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SOURCE Norgine B.V.