New drugs for type 2 diabetes get FDA approval

Three new types of diabetes medications have been approved for the treatment of adults with type 2 diabetes in the United States.
Nesina, Oseni and Kazano, all produced by Takeda Pharmaceuticals, were given the green light by the US Food and Drug Administration (FDA) last week following encouraging safety and efficacy data from various clinical studies.
Each tablet medication is based on aloglipti, a new dipeptidyl peptidase-4 inhibitor (DPP-4i) that helps stimulate the release of insulin after eating by inhibiting glucagon release, which in turn increases insulin secretion and lowers blood glucose levels .
Alogliptin is the only active ingredient in Nesina, whereas Oseni combines alogliptin with pioglitazone (Actos) and Kazano combines alogliptin with metformin, the first-line drug of choice for patients with type 2 diabetes .
Douglas Cole, President of Takeda Pharmaceuticals USA, 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.”
As part of the FDA approvals, Takeda will be required to conduct five post-marketing studies for aloglipti, including a cardiovascular outcomes trial to assure that the drug does not increase of the risk of heart attacks or strokes, and an enhanced program to monitor for liver abnormalities, serious cases of pancreatitis, and severe hypersensitivity reactions.
In addition, Oseni will come with a black box warning on the packaging to alert consumers about the increased risk of heart failure linked to pioglitazone use, while Kazano will include a boxed warning about the risk of lactic acidosis, which is linked to metformin use.
None of the newly approved drug treatments are suitable for patients with type 1 diabetes or people with diabetic ketoacidosis.

To Top