Pronova’s hypertriglyceridemia drug TAK-085 superior to EPA in Phase III trial
Lysaker/Osaka – Norwegian Pronova and its Japanese marketing partner Takeda Pharmaceuticals have a good chances of entering the Japanese drug market with their compound TAK-085, an omega-3 acid ethyl ester for treatment of for patients with hypertriglyceridemia. In a Phase III trial, a 4 gramme dose of TAK-085 reached the primary endpoint of percent change of from baseline in triglycerides at the end-of-treatment after 12 weeks and was superior to the active comparator EPA (1.8 grammes), which is already approved for the Japanese market. A dose of 2 grammes of TAK-085 was as effective as EPA. In addition, none of the drugs, which were tested on 200 patients each, demonstrated any statistically significant change in LDL cholesterol. TAK-085, which is already approved in Europe and the US, was safe and well tolerated, with the safety profile comparable to EPA. Takeda and Pronova said they are aiming to submit a New Drug Application in Japan before March 31, 2012. TAK-085 is a Omega 3-derived prescription drug containing EPA-E (highly purified eicosapentaenoic acid ethyl ester) and DHA-E (highly purified docosahexaenoic acid) and is marketed as LovazaTM in the U.S. with the indication of an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.Beside the hypertiglyceridemia indication, in certain European countries including Italy, France, Germany, Spain, the UK, it is also marketed for, adjuvant treatment in secondary prevention after myocardial infarction, in addition to other standard therapy (e.g. statins, antiplatelet drugs, betablockers, ACE inhibitors).