Drugs / insulin degludec/liraglutide
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | type 2 diabetes mellitus | 2013-05-31 | “Novo Nordisk today announced the submission to the European Medicines Agency of the marketing authorisation application for the approval of IDegLira” novonordisk.com ↗ |
| Filed | US (FDA) | — | type 2 diabetes mellitus | — | “IDegLira was submitted to the FDA in September 2015 under the US FDA's Prescription Drug User Fee Act V (PDUFA V) regulation.” novonordisk.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT02298192 | Nov 2014 → Dec 2015 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2016-11-21 | Novo Nordisk A/S | Regulatory Novo Nordisk får FDA-godkendelse for Xultophy® 100/3.6 i USA novonordisk.com ↗
Novo Nordisk meddeler i dag, at de amerikanske sundhedsmyndigheder (FDA) har godkendt registreringsansøgningen for Xultophy® 100/3.6. |
| 2016-11-21 | Novo Nordisk A/S | Regulatory Novo Nordisk receives US FDA approval for Xultophy® 100/3.6 novonordisk.com ↗
Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Xultophy® 100/3.6. |
| 2016-09-02 | Novo Nordisk A/S | Regulatory FDA forlænger registreringsprocessen for IDegLira med tre måneder novonordisk.com ↗
FDA meddelte Novo Nordisk at en tre-måneders forlængelse var påkrævet for at gennemgå ansøgningen og færdiggøre registreringsprocessen af IDegLira. |
| 2016-09-02 | Novo Nordisk A/S | Regulatory FDA extends regulatory review period for IDegLira by three months novonordisk.com ↗
Novo Nordisk today announced that the US Food and Drug Administration (FDA) has extended the regulatory review period for IDegLira, the fixed-ratio combination of insulin degludec and liraglutide in adults with type 2 diabetes. |
| 2016-05-24 | Novo Nordisk A/S | Regulatory FDA's rådgivende komite anbefaler godkendelse af IDegLira med stemmerne 16-0 novonordisk.com ↗
Bagsværd, den 24. maj 2016 - Novo Nordisk meddeler i dag, at Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC), som er en rådgivende komite for de amerikanske sundhedsmyndigheder (FDA) med stemmerne 16-0 anbefaler en godkendelse af IDegLira til behandling af voksne med type 2-diabetes. |
| 2016-05-24 | Novo Nordisk A/S | Regulatory IDegLira receives positive 16-0 vote in favour of approval from FDA Advisory Committee novonordisk.com ↗
Novo Nordisk today announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) voted 16-0, recommending the approval of IDegLira for the treatment of adults with type 2 diabetes. |
| 2016-05-20 | Novo Nordisk A/S | Regulatory FDA posts briefing materials prior to Advisory Committee meeting for IDegLira, a fixed combination product of insulin degludec and liraglutide novonordisk.com ↗
The briefing materials can be accessed on the FDA webpage |
| 2014-07-25 | Novo Nordisk A/S | Regulatory Novo Nordisk modtager positiv udtalelse om Xultophy® (IDegLira) fra de europæiske registreringsmyndigheder novonordisk.com ↗
Bagsværd, den 25. juli 2014 - Novo Nordisk meddelte i dag, at Xultophy® har fået en positiv udtalelse fra Udvalget for Humanmedicinske Lægemidler (CHMP) under Det Europæiske Lægemiddelagentur (EMA) med anbefaling om markedsføringstilladelse til behandling af type 2-diabetes hos voksne. |
| 2014-07-25 | Novo Nordisk A/S | Regulatory Novo Nordisk receives positive opinion on Xultophy® (IDegLira) from the European regulatory authorities novonordisk.com ↗
Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) adopted a positive opinion, recommending marketing authorisation for Xultophy® for the treatment of type 2 diabetes mellitus in adults. |
| 2013-05-31 | Novo Nordisk A/S | Regulatory Novo Nordisk indsender registreringsansøgning for IDegLira i EU til behandling af type 2-diabetes novonordisk.com ↗ |
| 2013-05-31 | Novo Nordisk A/S | Regulatory Novo Nordisk files for regulatory approval of IDegLira in the EU for the treatment of type 2 diabetes novonordisk.com ↗
Novo Nordisk today announced the submission to the European Medicines Agency of the marketing authorisation application for the approval of IDegLira, the combination product of insulin degludec (Tresiba®), the once-daily new-generation basal insulin analogue, with an ultra-long duration of action, and liraglutide (Victoza®), the once-daily human GLP-1 analogue. |
All press releases naming this drug 16 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | insulin degludec/liraglutide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02298192 ↗ |
| Known as | IDegLira | “AIMS: To compare the safety and efficacy of a simpler titration algorithm for insulin degludec/liraglutide (IDegLira) with that used in previous DUAL trials in insulin-naïve...” PMID 28124817 ↗ Mar 2017 |
| Route | Subcutaneous | “For subcutaneous (s.c., under the skin) injection, once daily.” NCT02298192 ↗ |