Takeda Receives Positive Opinion from EU on Three New Diabetes Treatments

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The Committee for Medicinal Products for Human Use (CHMP), of the European Medicines Agency (EMA), has issued a positive opinion for three new type 2 diabetes treatments developed by Takeda Pharmaceutical: Vipidia (alogliptin), a dipeptidyl peptidase IV (DPP-4) inhibitor, and for the fixed dose combination (FDC) therapies Vipdomet (alogliptin-metformin) and Incresync (alogliptin-pioglitazone).
 

Vipidia (alogliptin) is a DPP-4 inhibitor that address insulin deficiency by slowing the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). As a result, an increased amount of active incretins enables the pancreas to secrete insulin in a glucose-dependent manner, thereby assisting in the management of blood glucose levels.

Vipdomet is a fixed dose combination therapy for the treatment of type 2 diabetes, which combines Vipidia (alogliptin) and metformin in a single tablet. Vipdomet has been recommended by the CHMP to be indicated in the treatment of adult patients aged 18 years and older with type 2 diabetes mellitus. 

Incresync is a fixed dose combination therapy for the treatment of type 2 diabetes, which combines Vipidia (alogliptin) and pioglitazone (Actos) in a single tablet. Incresync has been recommended by the CHMP to be indicated as a second or third line treatment in adult patients aged 18 years and older with type 2 diabetes mellitus.

The CHMP opinion was based on data from a robust clinical trial programme involving more than 11,000 patients treated for up to four years, and two key studies, the one year data from the ENDURE trial and interim data from the cardiovascular outcomes trial EXAMINE.

The efficacy of alogliptin was studied as an adjunct to diet and exercise as an add-on therapy to several other classes of anti-diabetic medications, including metformin, pioglitazone, insulin and sulfonylureas (SUs). In these studies alogliptin 25mg tablets taken once-daily, demonstrated clinically and statistically significant reductions in HbA1c, with a good overall tolerability profile and low incidence of hypoglycemia compared with active control or placebo. It has also been shown to be weight neutral and will be available in a range of doses suitable to treat patients with all stages of renal impairment, including end stage renal disease (ESRD).

Study results indicated that alogliptin co-administered with either metformin or pioglitazone produced significant improvements in glycemic control compared with the respective monotherapies. Fixed dose combinations of alogliptin with either metformin or pioglitazone offer the additional benefit of combining two medications in one, which may help to reduce the number of pills patients must take each day.

Common adverse events reported with alogliptin include upper respiratory tract infection, nasopharyngitis, headache, abdominal pain, gastroesophageal reflux (GERD), pruritus and rash. In patients treated with alogliptin co-administered with metformin, common adverse events include upper respiratory tract infection, nasopharyngitis, headache, abdominal pain, GERD, diarrhea, vomiting, gastritis, gastroenteritis, pruritus and rash. Common adverse events reported with patients treated with alogliptin co-administered with pioglitazone include upper respiratory tract infection, sinusitis, nausea, dyspepsia, abdominal pain, pruritus, peripheral edema and increased weight.

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