Takeda gets US diabetes approval
pharmafile | January 28, 2013 | News story | Sales and Marketing | FDA, Nesina, Takeda, diabetes
Takeda has been given US approval for its diabetes drug Nesina and two variations on it for the treatment of type II diabetes.
The FDA has given the thumbs-up to Nesina (alogliptin) plus fixed-dose combinations Oseni (alogliptin and pioglitazone) and Kazano (alogliptin and metformin HCl).
A DPP-4 inhibitor, Nesina will compete with products with such as Merck’s Januvia. All three Takeda brands are indicated as adjuncts to diet and exercise.
It marks the end of a long road for Takeda, with the company delaying seeking approval of alogliptin to gather more data as long ago as 2009.
The Japanese manufacturer now hopes this will be a worthy successor to its once top-selling treatment Actos, which lost US patent protection in 2011.
Nesian is designed to slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide).
Oseni is the first US approval to contain a DPP-4i and a thiazolidinedione (TZD) in a single tablet.
Pioglitazone decreases insulin resistance, a condition in which the body does not efficiently use the insulin it produces to control blood glucose levels.
Takeda says it is on course to launch the trio of products in the summer.
Global trials involving more than 13,000 patients saw Nesina studied as a once-daily monotherapy and in combination with biguanides, TZDs, insulin and sulfonylureas.
In these studies, Nesina at a 25 mg dose once-daily demonstrated ‘clinically meaningful and statistically significant’ improvements in hemoglobin A1C compared to placebo.
Other study results suggested that alogliptin with either pioglitazone or metformin HCl produced significant improvements in glycemic control, compared with the respective monotherapies.
Adam Hill
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