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Pronova and Takeda Submit New Drug Application in Japan

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By: Sean Moloughney

Editor, Nutraceuticals World

In collaboration with Norway-based Pronova BioPharma ASA, Takeda Pharmaceutical Company Limited, Osaka, Japan, has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare for TAK-085 (omega 3-acid ethyl esters 90) for the treatment of hyperlipidemia.

TAK-085, discovered by Pronova, is the omega 3-derived prescription drug containing highly concentrated and purified EPA and DHA. It is already on the market in 56 countries including the U.S. and most European countries. 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.

This submission is based on the results of the phase 3 clinical trial to evaluate the efficacy and safety of TAK-085 for patients with hypertriglyceridemia, in comparison with an active comparator EPA product already marketed in Japan. The trial demonstrated that 4 grams per day (2 grams twice daily) of TAK-085 was statistically superior to 1.8 grams per day (0.6 grams thrice daily, the recommended daily dose) of the EPA, in lowering the percent change from baseline in triglycerides (primary endpoint measured at 12 weeks). TAK-085 was safe and well tolerated, with a safety profile comparable to the EPA.

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