Product
Juvisync
Approval Date
October 7, 2011
Release Date
October 26, 2011
Company
Merck
Class
Dipeptidyl peptidase 4 (DPP-4) inhibitor/HMG-CoA reductase inhibitor (statin)
Indication
Fixed-dose combination for use in adults who need both sitagliptin and simvastatin
Active Ingredient
Sitagliptin + simvastatin
Agency Roster
Draftfcb Health (pro/consumer)
Marketing Strategy/Execution
Merck’s latest diabetes product offers something different in the metabolics space: the only pill packing a DPP-IV inhibitor (Januvia) and, for diabetics who need its lipid-lowering ability, a statin (Zocor). Neither DPP-IV Onglyza, from Bristol-Myers Squibb/AstraZeneca, nor rival Tradjenta, from Boehringer Ingelheim/Eli Lilly, has such a pairing in its line (and none in development, for that matter). Starting with HCP-oriented marketing in 2011, and progressing to DTC after first quarter 2012, Juvisync’s campaign will educate audiences on the benefits via journals, CME, meetings and digital on the physician side, while consumers will get exposed through print, digital and possibly other channels. Look for DTC to stress Juvisync as part of a wider treatment program including diet, exercise and meal modification. Juvisync will be priced the same as Januvia.
Physician Outlook
Juvisync, the first combination drug to treat type 2 diabetes and high cholesterol represents “an intelligent choice” for patients who have both conditions. Patients with type 2 diabetes often have high cholesterol, a combination that can lead to increased risk of cardiovascular disease, renal disease, or blindness if poorly treated. The current and anticipated fixed dose combinations of sitagliptin/simvastatin offer adequate flexibility that should cover a good majority of patients with the exception of those with severe renal insufficiency or end stage renal disease. These patients require a 25 mg dose of sitagliptin which is not available as an FDC.
– Portia Gordon, PhD, VP, research & consulting, GfK HealthCare, Oct. 2011
Also in the Pipeline (courtesy of Adis R&D Insight)
No competitor compounds in Phase III or pre-registration
Source: Wolters Kluwer Pharma Solutions
Pharmacology
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Clinical Trials
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Adverse Reactions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Adults
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Children
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Precautions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
