Takeda delays diabetes drug in Europe

pharmafile | June 4, 2009 | News story | Research and Development, Sales and Marketing |  Takeda, diabetes 

Takeda is to delay seeking European approval of its key drug candidate alogliptin, and instead take another two years to gather more data to prove its efficacy.

The decision is a setback for the Japanese company, and has come after US regulators said in March they wanted more data for their own review of the drug.

Alogliptin (SYR-322) is a treatment for type 2 diabetes, and would be successor to Takeda's current top-selling treatment Actos, which accounts for around a quarter of its revenues but loses US patent protection in 2011.

Alogliptin belongs to a new class of diabetes drugs called DPP-4 inhibitors. The only approved product so far in the class is Januvia from Merck, which is available in the US.

Takeda originally planned to file for European approval of alogliptin and an alogliptin/Actos combination later this year, but now expects to delay their applications until to 2012.

It marks a blow for Takeda in its race to catch up with Merck as well other rival companies also working on the same mechanism.

Takeda's additional two-year study will evaluate the efficacy and safety of alogliptin compared to glipizide (Glucotrol by Pfizer) when used in combination with metformin.

The study will involve almost 2,500 patients with type 2 diabetes whose blood sugar level is inadequately controlled with metformin.