WC500169468

5.2. Medicines already authorised
RMP in the context of a variation 9 – PRAC-led procedure
See Annex 14.2
RMP in the context of a variation – CHMP-led procedure
5.2.1. Alogliptin – VIPIDIA (CAP)
Evaluation of an RMP in the context of a variation
Regulatory details:
PRAC Rapporteur: Menno van der Elst (NL)
Administrative details:
Procedure number(s): EMEA/H/C/002182/II/0001
Procedure scope: Update of SmPC sections 4.2, 4.4, 4.8, and 5.1 to reflect results of study 402, a
phase 3b, randomized, double-blind, placebo-controlled, event-driven study, designed to demonstrate
that no excess risk of a major adverse cardiovascular event (MACE) exists following treatment with
alogliptin compared with placebo when added to standard of care in adults with T2DM and acute
coronary syndrome (ACS)
MAH(s): Takeda Pharma A/S
Background
Vipidia is a centrally authorised medicine containing alogliptin, a dipeptidyl peptidase 4 (DPP-4)
inhibitor, indicated in adults aged 18 years and older with type 2 diabetes mellitus (T2DM) to improve
glycaemic control in combination with other glucose lowering medicinal products including insulin,
when these, together with diet and exercise, do not provide adequate glycaemic control.
The CHMP is evaluating a type II variation procedure for Vipidia, to include information from the results
of study 402 (phase 3b, randomized, double-blind, placebo-controlled, event-driven study, designed to
demonstrate that no excess risk of a major adverse cardiovascular event (MACE) exists following
treatment with alogliptin compared with placebo when added to standard of care in adults with T2DM
and acute coronary syndrome (ACS)). The PRAC is responsible for providing advice to the CHMP on the
necessary updates to the RMP to support this variation.
Summary of advice
The RMP version 6 for Vipidia (alogliptin) in the context of the variation under evaluation by
the CHMP was considered acceptable pending finalisation of the variation procedure by the
CHMP.
5.2.2. Alogliptin, pioglitazone – INCRESYNC (CAP)
Evaluation of an RMP in the context of a variation
Regulatory details:
PRAC Rapporteur: Menno van der Elst (NL)
Administrative details:
Procedure number(s): EMEA/H/C/002178/II/0002
9 In line with the revised variation regulation for submissions as of 4 August 2013
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/324055/2014 Page 28/73