Takeda and Pronova file for triglyceride lowererTAK-085 approval in Japan

Norway-based lipid therapies specialist Pronova BioPharma says that its partner, Takeda Pharmaceutical (TYO: 4502), has submitted a New Drug Application to the Japanese Ministry of Health, Labour and Welfare for TAK-085 (generic name: omega-3-acid ethyl esters 90) for the treatment of hyperlipidemia, high blood cholesterol.

TAK-085, discovered by Pronova, is the omega 3-derived prescription drug containing highly concentrated and purified EPA-E (eicosapentaenoic acid ethyl ester) and DHA-E (docosahexaenoic acid). It is already on the market in 56 countries including the USA and most European countries, using the name Omacor. In 2005, Takeda and Pronova entered into a license and supply agreement in which Takeda was granted the exclusive development and marketing right to this product in Japan. Financial terms of the deal were not disclosed.

Based on positive Phase III trial