AsianScientist (Oct. 2, 2012) – Pronova BioPharma ASA and Takeda Pharmaceutical Company Limited announced last week that the Japanese Ministry of Health, Labor and Welfare has approved a New Drug Application (NDA) of Lotriga granular capsule 2g for the treatment of hyperlipidemia.
Lotriga (generic name: omega-3-acid ethyl esters 90), 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 ethyl ester).
Lotriga is already on the market in 60 countries including the U.S. and Europe.
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. Lotriga will be the first prescription medicine in Japan that contains both EPA-E and DHA-E.
The results of the Phase III clinical trial conducted in Japan evaluated the efficacy and safety of Lotriga for Japanese patients with hypertriglyceridemia [baseline triglyceride level, 150 to 750 mg/dL], in comparison with an active comparator EPA (eicosapentaenoic acid, 0.6g thrice daily, recommended daily dose) product.
The trial demonstrated that 2g (once daily) of Lotriga was equally, and 4g (2g twice daily) of Lotriga was statistically superior to the EPA, in lowering the percent change from baseline in triglycerides. Lotriga was safe and well tolerated, with a safety profile comparable to the EPA.
According to the Takeda website, the recommended dosage of Lotriga in adults is 2g of Omega-3-acid ethyl esters is orally administered immediately after meals once a day. In the case of high triglyceride level, the dose can be increased to 2g twice a day.
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