FDA approved the first dipeptidyl peptidase IV (DPP IV) inhibitor Januvia (sitagliptin phosphate) Oct. 16 for treatment of type 2 diabetes.

Januvia is approved for use as a monotherapy or as combination therapy with either metformin or thiazolidinediones (TZDs) when either of these drugs, along with diet and exercise, does not adequately control blood sugar.

With Januvia, Merck receives its fifth new product approval this year. Merck's Zolinza (vorinostat) for cutaneous T-cell lymphoma was approved Oct. 6 (¹ Also see "Merck’s Zolinza Approved For Rare Skin Cancer" - Pink Sheet, 6 October, 2006.). The tally includes three vaccines approved earlier this year.

Januvia's approval comes just weeks before the estimated user fee date of Novartis' DPP IV inhibitor Galvus (vildagliptin). Novartis is currently conducting a head-to-head Phase IIIb clinical trial comparing Galvus to TZDs (² Also see "Galvus Trial May Show Potential For Modifying Type 2 Diabetes Treatment Guidelines" - Pink Sheet, 11 October, 2006.).

-Daniel Poppy (d.poppy@elsevier.com)

DPP IV Inhibitor Januvia First Out Of The Gate

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