Safety, efficacy problems sink Takeda drug

Japan's Takeda has walked away from development of its once-promising cholesterol drug TAK-475. The first sign of trouble came late in October, when the FDA recommended Takeda stop trials using higher doses of TAK-475 after seeing signs of elevated enzymes that indicate possible liver damage. Takeda discontinued TAK-475 development because, according to a release, the drug's profile was not superior to existing marketed drugs from both efficacy and safety standpoints. TAK-475 is a squalene synthase inhibitor which, had it been successful, would have been the first drug of its kind on the market. Takeda badly needs another blockbuster in its pipeline to make up for the loss of Actos patent protection in 2011.

In order to fill the gap, Takeda said it will aim 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 development projects in the late stage such as Hematide, a treatment for chronic kidney disease related anemia and cancer related anemia, and Lu AA21004, a treatment for mood and anxiety disorders."

- see Takeda's statement

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