– Norgine B.V. today announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for PLENVUR (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.
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PLENVUR has also been approved by the Lyfjastofnun, Icelandic Medicines Agency.
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, shown to be superior in providing high-quality cleansing in the colon ascendens, an important area for adenoma detection.[2]
Dr Alastair Benbow, Chief Development & Medical Officer, Norgine, said, “We look forward to making PLENVUR available to physicians and patients, to improve the quality of colonoscopy. PLENVUR has the potential to become the gold standard and replace other bowel preparations, and is part of our ongoing commitment to bring innovative products to market in gastroenterology, one of our core areas of expertise.”
The approval was based on data from the Phase III clinical trial programme, consisting of three multicentre, randomised, parallel group studies.
Colonoscopy is a vital screening procedure to detect colorectal cancer, the second most common cause of cancer-related mortality in Europe, with 412,000 new diagnoses every year.[3] In the UK there were more than 41,000 new cases of colorectal cancer in 2014, and more than 15,000 deaths, making it the second most common cause of cancer death.[4]
Norgine manufactures PLENVUR globally and will commercialise the product through its infrastructure in Europe and Australia and through its commercial partners in the rest of the world.
View the full release on http://www.norgine.com/
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.
[3] Zavoral M et al. Colorectal cancer screening in Europe. World J Gastroenterol 2009;15(47):5907-5915
[4]http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/bowel-cancer (Accessed September 2017)
Norgine Media ContactsIsabelle Jouin, T: +44(0)1895-453643 Follow us @norgine
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