Market Watch - JARDIANCE
Boehringer Ingelheim (Malaysia) Sdn Bhd
Jardiance® (empagliflozin) is the first type 2 diabetes medicine in Malaysia to include cardiovascular death reduction data in its label.
•The National Pharmaceutical Regulatory Agency in Malaysia has approved an update in the Jardiance® (empagliflozin) label to include a change in the indication statement.
•Jardiance® is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus (T2DM) as an adjunct to diet and exercise.
•The approved product information now includes data on the reduction of risks of cardiovascular (CV) death in patients with T2DM and established CV disease in addition to data on the improvement of blood sugar control.
•Jardiance® is the only oral treatment for type 2 diabetes that has been shown to reduce the risk of CV death in a dedicated CV outcome trial to-date.
•This is the first time the National Pharmaceutical Regulatory Agency in Malaysia approved the use of a diabetes treatment for its effect on both blood glucose control and CV events.
•The update of the Jardiance® indication by the National Pharmaceutical Regulatory Agency in Malaysia follows the approval by the U.S. Food and Drug Administration and European Commission to include the CV outcome data in the label in January 2017.
•The updated indication approved by the National Pharmaceutical Regulatory Agency in Malaysia is as follows:
Jardiance® is indicated in the treatment of T2DM to improve glycaemic control in adults as:
– monotherapy when diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance.
– a combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.
•Jardiance® is indicated in patients with type 2 diabetes mellitus and established CV disease to reduce the risk of CV death.
•To prevent CV death, Jardiance® should be used in conjunction with other measures to reduce CV risk in line with the current standard of care.
References: Package insert of Jardiance® (last revised September 2017) PC-MY-100249 Metabolism Jardiance