Takeda Submits New Drug Application for TAK-085
Takeda has submitted a New Drug Application in Japan for TAK-085 for the treatment of hyperlipidemia.
Pronova BioPharma and Takeda Pharmaceutical announced Thursday that Takeda submitted a New Drug Application (NDA) to the Japanese regulators for TAK-085 (omega-3-acid ethyl esters 90) for the treatment of hyperlipidemia.
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 [baseline triglyceride level, 150 to 750 mg/dL], in comparison with an active comparator EPA (eicosapentaenoic acid) product already marketed in Japan.
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
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