NOVO — Tresiba FDA Review (NDA/BLA 203314, 2018)
NOVO · 2018 · FDA Review (Drugs@FDA)
Report summary
The FDA approved Novo Nordisk's Tresiba (insulin degludec) on March 26, 2018, for glycemic control in diabetes patients aged 1 year and older. This approval incorporated data from the DEVOTE cardiovascular outcomes trial, which demonstrated Tresiba's non-inferiority for major adverse cardiovascular events (MACE) compared to insulin glargine U-100 in Type 2 diabetes patients at high cardiovascular risk. DEVOTE also showed Tresiba's superiority in reducing severe hypoglycemia, including nocturnal events, compared to insulin glargine. Efficacy trials confirmed Tresiba's non-inferiority in HbA1c reduction across various populations, with similar overall safety profiles to comparators, though Tresiba showed a slightly greater reduction in fasting plasma glucose. The prescribing information was updated to reflect these findings, along with warnings and adverse reactions.
Key findings — cited to the page
| Initial U.S. Approval | 2015 | TRESIBA (Insulin Degludec) · United States · p.10 |
| NDA approval date | September 2015 | Tresiba (insulin degludec) · United States · p.94 |
| NDA/BLA number | 203314 | Tresiba · United States · p.68 |
| Date of Submission Receipt | May 26, 2017 | Tresiba · United States · p.68 |
| PDUFA Goal Date | March 26, 2018 | Tresiba · United States · p.68 |
| Recommended Action | Approval | Tresiba · United States · p.68 |
| Approval Date | September 2015 | Tresiba · United States · p.69 |
| Postmarketing Requirement (PMR) number | 2954-2 | Tresiba · United States · p.69 |
| Original NDA Submission Date | September 29, 2011 | Tresiba · United States · p.69 |
| Advisory Committee Meeting Date | November 8, 2012 | Tresiba · United States · p.69 |
| Complete Response (CR) Letter Date | February 8, 2013 | Tresiba · United States · p.69 |
| Number of US sites | 271 | DEVOTE · United States · p.411 |
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 →