Japan´s Takeda Pharmaceutical Co announced it has filed with the U.S. health regulators for approval to market a combined tablet of its SYR-322 – in the family of drugs known as DPP-4 inhibitors - and Actos diabetes drugs for treating type 2 diabetes.

Takeda is currently waiting for U.S. approval of SYR-322 (alogliptin) as a monotherapy, filed at the end of February 2008, and if approved, it would be the second DPP-4 inhibitor to enter the U.S. market after Merck´s Januvia in 2006.

SYR-322 is a successor candidate for Takeda´s best-selling Actos – with sales of $ 958 million dollars in the first half of this year – as it will be losing patent protection in the U.S. in 2011.

Takeda expects to receive approval of the combination drug in about 10 months at the earliest.
Another DPP-4 inhibitor in the works is Bristol-Myers Squibb/AstraZeneca Plc´s Onglyza (saxagliptin).
On the other hand, Novartis AG decided – after a rejection by the FDA – not to apply for approval to market Galvus in the U.S., or its combo Eucreas.