NOVO NORDISK INC — Levemir FDA Review (NDA/BLA 021536, 2020)
NOVO NORDISK INC · 2020 · FDA Review (Drugs@FDA)
Report summary
The FDA approved Novo Nordisk's Levemir (insulin detemir) on February 2, 2015, via sNDAs S-031 and S-051. This approval primarily focused on labeling revisions to include warnings against sharing pens due to bloodborne pathogen transmission risks. The report details Levemir's indications, dosage, administration, and adverse reactions, including hypoglycemia rates. Levemir demonstrated lower severe hypoglycemia rates than NPH in Type 2 Diabetes and similar rates in pregnant women with Type 1 Diabetes, with no adverse impact on pregnancy outcomes. A 26-week trial (Study H) also evaluated Levemir as an add-on therapy. Regulatory updates also addressed storage conditions for Levemir FlexTouch pens and vials. The FDA's DMPP and DMEP collaborated extensively to finalize these critical safety labeling changes for Levemir and other insulin products.
Key findings — cited to the page
| Non-severe hypoglycemia, percent of patients | 64.3 % | Study E · p.17 |
| Severe hypoglycemia, percent of patients with at least 1 event | 4.0 % | Study F · p.17 |
| Severe hypoglycemia, percent of patients with at least 1 event | 2.5 % | Study E · p.17 |
| Non-severe hypoglycemia, percent of patients | 40.5 % | Study E · p.17 |
| Non-severe hypoglycemia, events/patient/year | 6.9 events/patient/year | Study E · p.17 |
| Severe hypoglycemia, percent of patients with at least 1 event | 1.5 % | Study F · p.17 |
| Approval Date | February 02, 2015 | Levemir · p.1 |
| Severe hypoglycemia, percent of patients with at least 1 event | 0.4 % | Study E · p.17 |
| Severe hypoglycemia, events/patient/year | 0.01 events/patient/year | Study E · p.17 |
| Severe hypoglycemia, events/patient/year | 0.08 events/patient/year | Study E · p.17 |
| Non-severe hypoglycemia, events/patient/year | 3.5 events/patient/year | Study E · p.17 |
| Severe hypoglycemia, events/patient/year | 0.04 events/patient/year | Study F · p.17 |
Source: NOVO NORDISK INC ↗ · 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 →