Shares in Takeda Pharmaceutical Co have fallen on the news that the Japanese drugmaker’s new type 2 diabetes drug alogliptin will not be filed in Europe until 2012.

The Osaka-based group says that it has initiated an additional long-term study to evaluate alogliptin compared to glipizide when used in combination with metformin in 2,500 subjects with type 2 diabetes, whose blood sugar level is inadequately controlled with the latter. Once the results are known, Takeda expects to have “a more robust data set necessary to ensure its approval”, so expects to submit marketing authorisation applications for alogliptin and a combination of the drug, which is also known as SY-322, with the blockbuster Actos (pioglitazone) in 2012.

Takeda was expected to file alogliptin in the next few weeks so the change in strategy represents a considerable delay. The news comes three months after the US Food and Drug Administration said it needed more data to evaluate the treatment.

In March, the agency noted that although the New Drug Application for alogliptin was filed prior to fresh guidelines laid out in December, the FDA “does not believe that the amount of existing alogliptin clinical data is sufficient to meet certain statistical requirements in the new guidance”. The Prescription Drug User Fee Act date scheduled for alogliptin is June 26.

Alogliptin, a dipeptidyl peptidase IV (DPP-4) inhibitor, is seen as vital to Takeda’s future success as it prepares for life after Actos, which loses patent protection in the USA in 2011. If approved, the drug would compete with Merck & Co's DPP-4 inhibitor Januvia (sitagliptin), which is well-established on the market.