MSD — Januvia FDA Review (NDA/BLA 021995, 2015)
MSD · 2015 · FDA Review (Drugs@FDA)
Report summary
The FDA approved a supplemental NDA for Januvia (sitagliptin) in 2009, mandating significant safety labeling changes. These changes primarily concern the risk of acute pancreatitis, including necrotizing pancreatitis, and cutaneous vasculitis, based on postmarketing observations. The approval required a Medication Guide and REMS. While Januvia effectively improves glycemic control in type 2 diabetes, its prescribing information now includes warnings for pancreatitis and hypersensitivity reactions, with dosage adjustments for renal impairment. The review involved extensive analysis of reported cases, comparison to other antidiabetic drugs, and debate over causality, ultimately leading to updated labeling for both Januvia and Janumet.
Key findings — cited to the page
| Safety Information Requirement Date | October 16, 2009 | Januvia (sitagliptin) · p.4 |
| FDA AERS database cases of necrotizing pancreatitis associated with sitagliptin | 2 cases | sitagliptin · p.15 |
| Pancreatitis reporting rate for sitagliptin (OSE data) | 70 cases per million-person years | Januvia, Janumet · United States · p.63 |
| Adverse Event | acute pancreatitis, including fatal and non-fatal hemorrhagic and necrotizing pancreatitis | JANUVIA · p.6 |
| FDA AERS database cases of pancreatitis associated with sitagliptin | 88 cases | sitagliptin · p.15 |
| Approval date for Januvia in U.S. | October 16th 2006 | Januvia · United States · p.47 |
| Exenatide approval date | April 2005 | Byetta · United States · p.64 |
| Approval date for Janumet in U.S. | March 30th, 2007 | Janumet · United States · p.47 |
| Sitagliptin approval date | October 16th 2006 | Januvia · United States · p.64 |
| Sitagliptin/metformin FDC approval date | March 30th, 2007 | Janumet · United States · p.65 |
| U.S. cases in OSE AERS analysis | 9 cases | Januvia, Janumet · United States · p.54 |
| Postmarketing study requirement | A 3-month pancreatic safety study in a diabetic rodent model treated with sitagliptin. | sitagliptin · p.18 |
Source: MSD ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →