EMA CHMP issues positive opinion for label updates to Takeda's Vipidia, Vipdomet and Incresync

Published on July 30, 2014 at 10:04 AM · No Comments

Takeda Pharmaceuticals International GmbH (“Takeda”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued positive opinions for updates to the Summary of Product Characteristics (SmPC) for VipidiaTM (alogliptin) and the fixed-dose combination (FDC) therapies VipdometTM (alogliptin and metformin) and IncresyncTM (alogliptin and pioglitazone). If the recommendation is formally adopted by the European Commission alogliptin for the treatment of Type 2 diabetes would include demonstrated cardiovascular (CV) safety outcomes data in its labeling. Type 2 diabetes is the most common form of diabetes, accounting for 85-95 percent of all cases and affecting 382 million people worldwide.

The CHMP recommendation for each of these therapies includes updated findings from two clinical studies. Proposed changes to the SmPC for Vipidia, Vipdomet, and Incresync include additional information from the CV safety outcomes trial EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome). Additionally, the proposed changes for Vipidia and Vipdomet also include updated findings from the ENDURE (Efficacy and Safety of Alogliptin Plus Metformin Compared to Glipizide Plus Metformin in Subjects With Type 2 Diabetes Mellitus) clinical study. EXAMINE was conducted with 5,380 Type 2 diabetes patients, with recent acute coronary syndrome (ACS) and high underlying CV risk. EXAMINE evaluated the effect of treatment with alogliptin in addition to standard of care, versus placebo in addition to standard of care, on major adverse CV events (MACE). ENDURE was a three-arm, multi-center, randomized, double-blind, active-controlled study evaluating the durability of the safety and efficacy of once-daily alogliptin compared to glipizide, each in combination with metformin.

“We’re encouraged by the positive opinions for Vipidia, Vipdomet and Incresync as cardiovascular disease is the leading cause of morbidity and mortality in patients with Type 2 diabetes,” said Elisabeth Genestin, MD, cardiometabolic medical affairs director, Europe & Canada, Takeda. “Having a robust data set demonstrating that alogliptin does not increase the risk of cardiovascular outcomes is important for the healthcare professionals who are treating people with Type 2 diabetes.”

The most substantive change proposals include:

  • An update to the Clinical Safety section:

Findings from EXAMINE demonstrated that use of alogliptin did not increase the risk of having a MACE compared to placebo [Hazard Ratio: 0.96; 1-sided 99% Confidence Interval: 0-1.16]. In the alogliptin group, 11.3% of patients experienced a MACE compared to 11.8% of patients in the placebo group. This further confirms results from a previously conducted pooled analysis of the data from 13 studies, where the overall incidences of CV death, non-fatal myocardial infarction and non-fatal stroke were comparable in patients treated with 25 mg alogliptin, active control or placebo. In addition, in this prospective randomized controlled CV outcomes study, investigator reported events of hypoglycaemia were similar in patients receiving placebo (6.5%) and patients receiving alogliptin (6.7%) both in addition to standard of care.

  • An update to the Clinical Efficacy section:

Results from ENDURE demonstrated that the addition of 25 mg alogliptin once daily to metformin hydrochloride therapy for glycemic control resulted in improvements from baseline in HbA1c at Week 52 that were sustained at Week 104. At Week 52, the HbA1c reduction by alogliptin plus metformin was similar to that produced by glipizide plus metformin. At week 104 the HbA1c reduction by alogliptin plus metformin was greater than that produced by glipizide plus metformin.  

The CHMP/EMA opinions for Vipidia, Vipdomet, and Incresync will now be sent to the European Commission to update the respective product Commission Decisions. The European Commission first granted Marketing Authorization for Vipidia, Vipdomet, and Incresync in September 2013.

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