Takeda Pharmaceutical Co has submitted a New Drug Application to US regulators to get marketing approval for its new dipeptidyl peptidase-4 inhibitor SYR-322 and the blockbuster Actos combined in a single tablet for the treatment of type 2 diabetes.

Takeda is currently waiting for approval from the US Food and Drug Administration for SYR-322 (alogliptin) as a monotherapy. The drug was filed in January this year and if approved, it would be the second DPP-4 inhibitor to enter the market across the Atlantic after Merck & Co’s Januvia (sitagliptin) in 2006.

If approved, the combination of alogliptin and Actos (pioglitazone) would be the first type 2 diabetes treatment option which includes a DPP-4 inhibitor with thiazolidinedione. Yasuchika Hasegawa, president of Takeda, said that “given the increased global incidence” of the disease and the need for new drugs, “we will strive to provide alogliptin/Actos as a potentially important treatment option”.

The NDA submission is supported by two Phase III clinical trials, involving more than 2,000 patients worldwide. The studies showed that alogliptin/Actos produced significant improvements in glycaemic control and measures of insulin resistance and beta-cell function. The combo was generally well-tolerated and the side effects included headache, cold-like symptoms and back pain.

Both the combination treatment and SYR-322 are seen as vital to Takeda’s future success seeing as it prepares for life after Actos, which loses patent protection in the USA in 2011. Sales of the drug for the year ended March 2008 climbed 17.8% to 396.2 billion yen, or around $3.8 billion.