FDA approves Takeda diabetes treatments

Three new Type 2 therapies for diabetes from Takeda have been given approval by the US Food and Drug Administration (FDA).

It has approved NESINA (alogliptin) and the fixed-dose combination (FDC) therapies OSENI (alogliptin and pioglitazone) and KAZANO (alogliptin and metformin HCI) for the treatment of the condition.

NESINA is a depetidyl peptidase-4 inhibitor that is created to slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinitropic peptide).

On the other hand, OSENI is the first product in the US to feature a DDP-4i and a hiazolidinedione (TZD) in a single tablet, whereas KAZANO merges alogliptin with metformin HCI in one tablet.

The most common adverse events reported with NESINA include nasopharyngitis, headache and upper respiratory tract infection, while negative reactions to OSENI range from nasopharyngitis to back pain and upper respiratory tract infection.

With regard to KAZANO, side effects such as upper respiratory tract infection, nasopharyngitis, diarrhea, hypertension, headache, back pain and urinary tract infection have been found to take place.

Takeda is aiming to commercially launch NESINA, OSENI and KAZANO this summer.

Douglas Cole, president, Takeda Pharmaceuticals, said: "Takeda is pleased with the FDA approval of NESINA, OSENI and KAZANO for the treatment of type 2 diabetes, a therapeutic category in which we have more than twenty years of clinical and patient experience.

"Millions of people are affected by diabetes and, as a leader in the diabetes arena, Takeda is dedicated to working to advance patient care and helping to meet the needs of this growing patient population."

Type 2 diabetes is currently the most common form of the disease and affects millions of people around the world.

In the US alone, 23 million people currently live with the condition, with multiple medications often needed to help them manage their blood glucose levels, highlighting the severe nature of the disease.

Figures from the International Diabetes Federation also show that the global health care expenditures for diabetes type 1 and 2 were estimated at $471.6 billion (£299 billion) in 2012.

Posted by Ben Evans