MSD — Januvia FDA Review (NDA/BLA 021995, 2015)
MSD · 2015 · FDA Review (Drugs@FDA)
Report summary
This FDA approval package for Januvia (sitagliptin) details supplemental new drug applications for expanded indications and safety labeling changes. It covers Januvia's approval for combination therapies with metformin, PPARγ agonists, and insulin, demonstrating efficacy in improving glycemic parameters (HbA1c, FPG) across various patient populations, including those with renal insufficiency. The document highlights safety concerns, particularly the risk of pancreatitis, leading to a Risk Evaluation and Mitigation Strategy (REMS) and postmarketing study requirements. Updates to the Package Insert include revised Indications and Usage, Warnings and Precautions, and Adverse Reactions sections, with specific attention to hypoglycemia risk in combination with sulfonylureas or insulin. Regulatory updates also address labeling changes for acute pancreatitis risk for both Januvia and Janumet.
Key findings — cited to the page
| Dosage for moderate renal insufficiency (CrCl ≥30 to <50 mL/min) | 50 mg once daily | JANUVIA · p.12 |
| Dosage for severe renal insufficiency and ESRD (CrCl <30 mL/min) | 25 mg once daily | JANUVIA · p.12 |
| Hypoglycemia incidence (JANUVIA + Glimepiride +/- Metformin) | 12.2 % | JANUVIA · p.16 |
| Hypoglycemia incidence (Placebo + Glimepiride +/- Metformin) | 1.8 % | · p.16 |
| Hypoglycemia rate (JANUVIA + Glimepiride +/- Metformin) | 0.59 episodes/patient-year | JANUVIA · p.16 |
| Hypoglycemia rate (Placebo + Glimepiride +/- Metformin) | 0.24 episodes/patient-year | · p.16 |
| Severe hypoglycemia incidence (JANUVIA + Glimepiride +/- Metformin) | 0.0 % | JANUVIA · p.16 |
| Severe hypoglycemia incidence (Placebo + Glimepiride +/- Metformin) | 0.0 % | · p.16 |
| Hypoglycemia incidence (JANUVIA + Insulin +/- Metformin) | 15.5 % | JANUVIA · p.16 |
| Hypoglycemia incidence (Placebo + Insulin +/- Metformin) | 7.8 % | · p.16 |
| Hypoglycemia rate (JANUVIA + Insulin +/- Metformin) | 1.06 episodes/patient-year | JANUVIA · p.16 |
| Recommended dose | 100 mg once daily | JANUVIA · p.12 |
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 →