FDA Approves Juvisync, a Combination Drug to Treat Type 2 Diabetes and High Cholesterol

The FDA has approved Juvisync, a fixed-dose combination product containing the dipeptidyl peptidase 4 (DPP-4) inhibitor sitagliptin and the HMG-CoA reductase inhibitor simvastatin.  Sitagliptin is approved for use in combination with diet and exercise to improve glycemic control in adults with type 2 diabetes. Simvastatin is indicated for use with diet and excercise to treat multiple hyperlipoproteinemias. This combination product is indicated for patients who require treatment with both of these drugs.

Juvisync was approved in the following dosage strengths for sitagliptin/simvastatin: 100mg/10mg, 100mg/20mg, 100mg/40mg.  Merck is working on developing additional strengths containing sitagliptin 50mg as well. Pending availability of the combination tablets containing 50mg of sitagliptin, patients who require this dose should continue to use the single ingredient sitagliptin tablet. There is no plan to develop a combination product containing sitagliptin 25mg as use of this dose is quite low. Due to recent restrictions placed on the use of simvastatin 80mg, there will be not be a combination product containing this strength.

For more information call (800) 444-2080 or visit www.merck.com.