Takeda: Top-line Results of the Pivotal Phase 3 Clinical Trial of TAK-085 in Japan for Treatment of Hypertriglyceridemia
Takeda Pharmaceutical Company Limited and Pronova BioPharma ASA jointly announced the top-line results of a pivotal phase 3 clinical trial of TAK-085 (Compendial name: omega-3 acid ethyl esters 90).
This is a randomized, double-blind, phase 3 clinical trial to evaluate the efficacy and safety of TAK-085 for patients with hypertriglyceridemia, in comparison with an active comparator, EPA (eicosapentaenoic acid) product already approved in Japan.
The trial consists of three arms, with approximately 200 subjects each, of dosage and administration of 2g and 4g of TAK-085 a day respectively, and 1.8g of EPA a day. The trial demonstrated 4g of TAK-085 was statistically superior to 1.8g of EPA, the recommended daily dose, in lowering the percent change from baseline in triglycerides at the end-of-treatment (primary endpoint measured at 12 weeks). Both two grams of TAK-085 and 1.8g of EPA significantly reduced the same primary endpoint. Additionally, this study demonstrated no statistically significant change in LDL cholesterol in any of the three groups. TAK-085 was safe and well tolerated, with the safety profile comparable to EPA.
Takeda will conduct the full-analysis of the results together with Pronova, and is aiming to submit a New Drug Application in Japan within this fiscal year ending March 31, 2012.
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