FDA clears Eli Lilly, Boehringer Ingelheim's diabetes therapy Jentadueto (Ref: NASDAQ, PR Newswire, FinanzNachrichten, The Wall Street Journal)
January 31st, 2012
By: Matthew Dennis
Tags: Boehringer IngelheimDiabetesFDAGeneral PracticeInternal MedicineJentaduetoLillyMarketing & SalesRegulatory AffairsTradjenta
PrintEli Lilly and Boehringer Ingelheim announced that the FDA approved the combination therapy Jentadueto (linagliptin/metformin) for the treatment of adults with type 2 diabetes. The product combines the DPP-4 inhibitor Tradjenta (linagliptin), which was cleared by the agency last May, with metformin.
Specifically, Jentadueto was authorised by the regulator for use alone or in combination with a sulfonylurea to lower blood sugar in adults with type 2 diabetes. Eli Lilly and Boehringer Ingelheim noted that the approval was based on data from studies in which Tradjenta and metformin were evaluated as separate tablets, with bioequivalence of Jentadueto shown in healthy subjects. The companies said that in clinical trials, Jentadueto demonstrated placebo-corrected reductions in HbA(1c) levels of up to 1.7 percent.
In January 2011, Eli Lilly and Boehringer Ingelheim entered a deal to jointly develop and market several diabetes compounds, including Tradjenta