Eziclen® / Izinova® a new bowel cleansing preparation, is a sulphate-based formulation (sodium, magnesium and potassium sulphates).
The dose for cleansing the colon will require two administrations of about 0.5 litre / 16 ounces of the product diluted in water, each followed by about 1 litre / 32 ounces, of clear liquids, each.
The drug will be registered under the trade name Eziclen® in the large majority of the concerned EU countries and under the name Izinova® in the other few countries including France & UK
7 feb 2013
French drugmaker Ipsen and US partner Braintree Laboratories yesterday announced today that Eziclen/Izinova (BLI-800) has successfully completed its European decentralized registration procedure involving 16 countries, paving the way for a launch of the product before the end of 2013.
The product will be indicated in adults for bowel cleansing prior to any procedure requiring a clean bowel (eg, bowel visualization including bowel endoscopy and radiology or surgical procedure). Each European Union member states (France [reference member state], Belgium, Czech Republic, Estonia, Germany, Greece, Italy, Latvia, Lithuania, Luxemburg, the Netherlands, Poland, Portugal, Romania, Spain and UK) should now adopt a national decision within 30 days. In practice, the grant of the national marketing authorization may vary from one to several months, Ipsen noted.
Jean Fabre, senior vice president Intercontinental Operations and Franchise “Primary Care” at Ipsen, stated: “The completion of the decentralized procedure for Eziclen/Izinova (BLI-800) is an important step forward to national marketing authorizations in Europe. The availability of Eziclen/Izinova (BLI-800) will provide physicians and patients with a valuable agent for pre-colonoscopy colonic cleansing, particularly in the screening of colorectal cancer. This decision gives also perspectives for our plant in Dreux where Eziclen/Izinova will be manufactured”.
In 2009, Ipsen acquired the exclusive manufacturing, marketing and distribution rights of Braintree’s proprietary formulation BLI-800. The agreement covers countries within the EU, Commonwealth of Independent States, selected Asian countries (including China) and some North African countries. This product was approved by US Food and Drug Administrtion in 2010 and is marketed as Suprep Bowel Prep Kit.