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news.Takeda Pharmaceutical and Pronova BioPharma have released top-line results from a randomized, double-blind, Phase 3 clinical trial evaluating TAK-085, an Omega 3-derived prescription drug containing EPA-E (purified eicosapentaenoic acid ethyl ester) and DHA-E (purified docosahexaenoic acid).
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The Phase 3 trial investigated the safety and efficacy of TAK-085 in comparison with an active comparator, EPA (eicosapentaenoic acid) in patients suffering from hypertriglyceridemia.
The results of the trial showed that 4g of TAK-085 was superior to 1.8g of EPA, 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 reduced the same primary endpoint in the trial.
In the study, TAK-085 was safe and well tolerated, with the safety profile comparable to EPA.
TAK-085 is marketed as Lovaza in the US with the indication of an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (equal to or in excess of 500 mg/dL) hypertriglyceridemia.
In certain European countries including Italy, France, Germany, Spain and the UK, it is also marketed for, adjuvant treatment in secondary prevention after myocardial infarction, in addition to other standard therapy.
In 2005, Takeda and Pronova entered into a license- and supply agreement in which Takeda was granted an exclusive development and marketing right of the product in Japan.