NOVO — Saxenda FDA Review (NDA/BLA 206321, 2019)
NOVO · 2019 · FDA Review (Drugs@FDA)
Report summary
Saxenda (liraglutide injection) was FDA-approved in 2017 for chronic weight management in adults with specific BMI and comorbidities. Clinical trials demonstrated significant weight reduction and improved cardiometabolic parameters, but also revealed common adverse reactions, particularly gastrointestinal issues, and concerns regarding thyroid C-cell tumors, pancreatitis, gallbladder disease, and hypoglycemia. Carcinogenicity studies showed dose-related increases in thyroid C-cell adenomas and carcinomas. A supplemental NDA focused on a 3-year trial (1839) in pre-diabetic patients, showing efficacy in delaying T2DM onset and weight loss. However, high rates of missing data and discontinuations raised concerns about long-term durability. Safety findings from this trial highlighted increased incidence of pancreatitis, gallstone disease, and higher discontinuation rates due to adverse events in the Saxenda group. Psychiatric adverse events, including suicidal ideation, and a numerical imbalance in breast cancer cases were also noted, leading to post-marketing requirements. Pharmacokinetic interactions with common medications were also detailed.
Key findings — cited to the page
| Mean increase in resting heart rate | 2 to 3 bpm | Saxenda · p.15 |
| Patients with >10 bpm heart rate increase at two consecutive visits | 19 % | Placebo · p.15 |
| Cholecystitis incidence | 0.8 % | Saxenda · p.15 |
| Cholecystitis incidence | 0.4 % | Placebo · p.15 |
| Patients with >10 bpm heart rate increase at two consecutive visits | 34 % | Saxenda · p.15 |
| Supplement 004 Submission Date | June 24, 2016 | Saxenda (liraglutide) injection · p.4 |
| Supplement 006 Submission Date | January 12, 2017 | Saxenda (liraglutide) injection · p.4 |
| Acute pancreatitis incidence | 0.3 % | Saxenda · p.15 |
| Acute pancreatitis incidence | 0.1 % | Placebo · p.15 |
| Cholelithiasis adverse events | 2.2 % | Saxenda · p.15 |
| Cholelithiasis adverse events | 0.8 % | Placebo · p.15 |
| Patients with >20 bpm heart rate increase at two consecutive visits | 5 % | Saxenda · p.15 |
Source: NOVO ↗ · 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 →