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Norgine receives German regulatory approval for Plenvu for bowel cleansing in adults

Amsterdam, The Netherlands
Monday, February 12, 2018, 12:00 Hrs  [IST]

Norgine B.V has announced that the marketing authorisation for Plenvu for bowel cleansing in adults prior to any procedure requiring a clean bowel, has been granted by the German regulatory authority. The approval was granted under the European decentralised procedure, with the UK as reference state. Norgine anticipates launch of Plenvu in Germany later this year.

Plenvu is now approved for use in Australia, Austria, Belgium, Croatia, Denmark, Finland, France, Hungary, Iceland, Ireland, Italy, Norway, Portugal, Romania, The Netherlands and in the UK (using the trademark Pleinvue in Austria and The Netherlands).

Plenvu is already commercially available in the UK and Belgium.

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:

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 success, and superior to Moviprep in achieving ‘Excellent plus Good’ cleansing of the colon ascendens using the Harefield Cleansing Scale (HCS).

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: NER1006 was as effective as a trisulfate solution in achieving overall bowel cleansing success and ‘Excellent plus Good’ cleansing of the colon ascendens.

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 bowel cleansing success and ‘Excellent plus Good’ cleansing of 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.

 

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