Lucassin terlipressin regulatory update

Australia's Therapeutic Goods Administration ( TGA) approved Lucassin terlipressin to treat Type I hepatorenal syndrome (HRS) in patients who are being considered for a liver transplant. The synthetic analog of lysine-vasopressin is also approved in France, Ireland, Spain and South Korea for the indication. Lucassin has Orphan Drug status in Australia and Orphan Drug designation in the U.S., where the product is in Phase III testing. Terlipressin is approved as Variquel to treat esophageal varices under the European Mutual Recognition Procedure in Belgium, Denmark, Finland, France, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden and the U.K (see BioCentury, Dec. 7, 2009). ...