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[1] - an important area for adenoma detection[2]
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.
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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.[2]
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.
References
[1] 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.
[2] Lasisi F, et al. Expert Rev Gastroenterol Hepatol 2011; 5(6): 745-754.
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