Galvus (vildagliptin) - DPP-IV Inhibitor / Oral Antidiabetic Agent

Galvus (vildagliptin) - DPP-IV Inhibitor / Oral Antidiabetic Agent
drugdevelopment-technology.com

Key Data

Drug (brand / generic)Galvus (vildagliptin)Company / licenseeNovartisTherapy classDPP-IV inhibitorProduct descriptionInhibits action of DPP-IV, so delaying degradation of GLP-1Current indicationType 2 diabetesMarket sectorDiabetesDevelopment statusApproved Europe; pre-registration USFull specifications

Novartis' Galvus (vildagliptin) is a member of a new class of oral antidiabetic agents known as dipeptidyl peptidase IV inhibitors (DPP-IV) inhibitors or 'incretin enhancers'. Its mode of action is distinct from established antidiabetic medications and appears to include disease-modifying effects in patients with type 2 diabetes.

Galvus (vildagliptin), in advanced-stage development as a treatment for patients with type 2 diabetes, has now received the thumbs up from regulators in Europe. The EMEA has approved its use in combination with other anti-diabetic medications including metformin, sulfonylureas and thiazolidinediones. Approval has also been granted for Eucreas, a single tablet formulation of Galvus (vildagliptin) and metformin.

Meanwhile, regulatory approval in the US awaits the submission of additional data, which is not anticipated before mid-2009.

DPP-IV INHIBITION Ò DIABETES TREATMENT
Glucagon-like peptide-1 (GLP-1) and gastric inhibitor peptide (GIP) are naturally occurring hormones (incretins) that are released from cells in the gut in response to food. They bind to receptors on pancreatic beta cells stimulating the release of the hormone insulin, responsible for the regulation of blood sugar levels.

GLP-1 also reduces the secretion of glugacon, a hormone produced by the pancreas that stimulates the liver to convert glycogen to glucose, thus increasing blood sugar levels. Naturally produced GLP-1 has a very short half-life of less than two minutes.

Patients with type 2 diabetes have impaired incretin function and are thus unable to properly regulate their blood sugar levels, which can lead to adverse clinical sequelae. Novartis' Galvus (vildagliptin) works by inhibiting DPP-IV, an enzyme that breaks down GLP-1.

By delaying the degradation of GLP-1, vildagliptin extends the action of insulin while also suppressing the release of glucagon. This leads to a reduction in elevated blood glucose levels (hyperglycaemia) that is a characteristic feature of type 2 diabetes.

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