Takeda scraps late-stage cholesterol drug

Japanese drug major Takeda has discontinued the development of TAK-475 (lapaquistat acetate), an investigational compound studied for the treatment of hypercholesterolemia. The US Food and Drug Administration requested additional clinical data prior to submission of a New Drug Application for the agent and recommended the suspension of studies with higher doses.

Takeda says it decided to terminate TAK-475's development based on its view that the profile of the compound is not superior to existing marketed drugs from both efficacy and safety viewpoints. Japan's largest R&D-based drugmaker by sales said it will continue best efforts for the enhancement of its R&D pipeline, which is one of the operational targets in its 2006-2010 Medium-Term Management Plan, by accelerating the development projects in lifestyle-related or metabolic diseases and also in all other core therapeutic areas along with conducting in-house R&D activities, in-licensing and alliances.

Specifically, Takeda will continue strategic investments aiming for the earliest possible launch of SYR-322 and TAK-390MR of which NDAs are now under review by the FDA, and for earliest possible NDA submission of the late-stage development projects such as Hematide, a treatment for chronic kidney disease-related anemia and cancer-related anemia, and Lu AA21004, a peptide-based drug candidate for mood and anxiety disorders.