Norgine BV, a leading specialist pharmaceutical company with a direct commercial presence in all major European markets, announced marketing authorisation for Plenvu 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. Plenvu has also been approved in Australia. Norgine anticipates launches in these countries in 2018.

Plenvu 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). 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).

The approvals were 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: when administered using either dosing regimen, NER1006 was as effective as Moviprep in achieving overall bowel cleansing, and superior to Moviprep in achieving ‘Excellent plus Good’ cleansing of the colon ascendens.

CT 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: NER1006 was as effective as a trisulfate solution in achieving overall bowel cleansing success and ‘Excellent plus Good’ cleansing of the colon ascendens using the Harefield Cleansing Scale (HCS).

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: NER1006 was as effective as sodium picosulfate and magnesium salt solution at achieving overall successful bowel cleansing and ‘Excellent plus Good’ cleansing in the colon ascendens.

Plenvu (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 Plenvu and commercialises the product through its infrastructure in Europe and Australia and through its commercial partners in the rest of the world.

Plenvu (NER1006) is a novel, low-volume (1-litre) PEG-based bowel preparation for cleansing of the colon in preparation of colonoscopy. Effective bowel preparation is an important factor for a successful colonoscopy and for detecting adenomas and polyps. 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.