Takeda announced Thursday that it will delay the EU filing of experimental type 2 diabetes drug alogliptin, as well as a treatment combining the compound with Actos (pioglitazone), by about two and a half years to 2012 in order to conduct an additional long-term clinical study on the DPP-4 inhibitor. Company spokesperson Toshiyuki Ikeuchi said “the test would help us win approval with more certainty.”

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The two-year study will enrol almost 2500 subjects with type 2 diabetes, whose blood glucose level is inadequately controlled with metformin, and will evaluate “alogliptin compared to glipizide when used in combination with metformin.”

The move follows an announcement earlier this year that the FDA, which is currently reviewing alogliptin and is scheduled to render a decision by June 26, requested more data for the drug. A Takeda spokesperson specified that the decision to conduct a new trial was made without prompting by EU regulators and said the trial will be separate from an additional study planned for the US market.

Commenting on the development, analyst Yo Mizuno of the Daiwa Research Institute said “the delay in Europe is not a surprise… It has been largely expected, as a delay in the US of one to two years has become the market consensus.”

Source: FirstWord

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