Tresiba(insulin degludec)
Metabolic· 2078 cited findings· 2 source documents
Company: NOVO →
What the regulatory reviews say
Tresiba (insulin degludec) received initial U.S. approval in 2015 (NDA/BLA 203314). The FDA review documents indicate an approval recommendation with a PDUFA Goal Date of March 26, 2018. The original NDA was submitted on September 29, 2011.
Efficacy findings from clinical trials showed reductions in HbA1c and FPG. For instance, HbA1c change from baseline ranged from -0.19 to -0.57, and the proportion of patients achieving HbA1c < 7% ranged from 37.0% to 40.9%. FPG change from baseline ranged from -23.9 to 59.6. HbA1c reduction differences from baseline were observed at 0.09%, 0.15%, and 0.17%.
Common safety findings included nasopharyngitis (23.9% in Adult Type 1 Diabetes, 12.9% in Adult Type 2 Diabetes), upper respiratory tract infection (11.9% in Adult Type 1 Diabetes, 8.4% in Adult Type 2 Diabetes), and headache (11.8% in Adult Type 1 Diabetes, 8.8% in Adult Type 2 Diabetes). Severe hypoglycemia events were reported in 4.9% of patients.
Key figures — cited to the source page
| HbA1c change from baseline | -0.57 | NOVO — Tresiba FDA Review (NDA/BLA 203314, 2018), p.31 |
| Proportion Achieving HbA1c < 7% | 40.9 % | NOVO — Tresiba FDA Review (NDA/BLA 203314, 2018), p.31 |
| Nasopharyngitis (Adult Type 1 Diabetes) | 23.9 % | NOVO — Tresiba FDA Review (NDA/BLA 203314, 2018), p.16 |
| Nasopharyngitis (Adult Type 2 Diabetes) | 12.9 % | NOVO — Tresiba FDA Review (NDA/BLA 203314, 2018), p.16 |
| Patients with severe hypoglycemia events | 4.9 % | NOVO — Tresiba FDA Review (NDA/BLA 203314, 2018), p.42 |
| Initial U.S. Approval | 2015 | NOVO — Tresiba FDA Review (NDA/BLA 203314, 2018), p.10 |
| NDA/BLA number | 203314 | NOVO — Tresiba FDA Review (NDA/BLA 203314, 2018), p.68 |
| Recommended Action | Approval | NOVO — Tresiba FDA Review (NDA/BLA 203314, 2018), p.68 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.