Vipidia(Alogliptin)

Metabolic· 788 cited findings· 1 source document

Company: Takeda Pharmaceutical Company Limited →

What the regulatory reviews say

Vipidia (Alogliptin) is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated for the treatment of type 2 diabetes mellitus. Regulatory marketing authorizations include the US (January 25, 2013), Mexico (August 29, 2012), Korea (May 31, 2013), and China (July 16, 2013). A CHMP positive opinion for Marketing Authorisation was issued on July 25, 2013. Alogliptin and alogliptin/pioglitazone FDC were first approved in Japan in April 2010.

Key efficacy findings include a reduction in FPG LS mean difference of -1.199 for Alogliptin 12.5 mg versus Placebo and -1.541 for Alogliptin 25 mg versus Placebo. The drug demonstrated DPP-4 inhibition IC50 values ranging from 6 to 18 nM. Plasma glucose AUC(0-90min) reduction was 75% of control, and plasma insulin levels increased by 146% of control. Oral bioavailability ranged from 41-45% to 72-88%.

Regarding safety, the clinical recommended dose is 25 mg. Hypoglycaemic events were observed at 2.5% for MET+alogliptin 12.5 mg and 1.4% for MET+alogliptin 25 mg, compared to 23.8% for MET+glipizide. Vipidia showed an hERG channel current inhibition IC50 of >30 μmol/L and CYP2D6 inhibition IC50 of ≥40 µM.

Key figures — cited to the source page

FPG LS mean difference (A12.5 vs Placebo)	-1.199	Takeda Pharmaceutical Company Limited — Vipidia EMA EPAR pub, p.54
FPG LS mean difference (A25 vs Placebo)	-1.541	Takeda Pharmaceutical Company Limited — Vipidia EMA EPAR pub, p.54
DPP-4 inhibition IC50	6 to 18 nM	Takeda Pharmaceutical Company Limited — Vipidia EMA EPAR pub, p.13
Plasma glucose AUC(0-90min) reduction	75 % of control	Takeda Pharmaceutical Company Limited — Vipidia EMA EPAR pub, p.14
Hypoglycaemic events (MET+alogliptin 12.5 mg)	2.5%	Takeda Pharmaceutical Company Limited — Vipidia EMA EPAR pub, p.48
Hypoglycaemic events (MET+alogliptin 25 mg)	1.4%	Takeda Pharmaceutical Company Limited — Vipidia EMA EPAR pub, p.48
Marketing Authorisation in US	25 January 2013	Takeda Pharmaceutical Company Limited — Vipidia EMA EPAR pub, p.6
CHMP positive opinion for Marketing Authorisation	25 July 2013	Takeda Pharmaceutical Company Limited — Vipidia EMA EPAR pub, p.7

Source documents

Takeda Pharmaceutical Company Limited — Vipidia EMA EPAR public assessment report (EMEA/H/C/002182, 2013) (2013)

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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.