drugset

Drugs / insulin degludec/liraglutide

Follow last change Oct 2016 re-read 3 minutes ago

insulin degludec/liraglutide

also known as IDegLira

Other / unclassified

Developed for: type 2 diabetes mellitus
Investigated by: Novo Nordisk A/S

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	“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	—	“The NDA for IDegLira was submitted to the FDA in September 2015 under the FDA's Prescription Drug User Fee Act V (PDUFA V) regulation.” novonordisk.com ↗ “IDegLira was submitted to the FDA in September 2015 under the FDA's Prescription Drug User Fee Act V (PDUFA V) regulation.” novonordisk.com ↗

Trials 1

today NCT01618162 · Ph 3

201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 3	NCT01618162	Aug 2012 → Oct 2013	type 2 diabetes mellitus	Novo Nordisk A/S	Completed	Met primary

News releases announcing trial results or a regulatory action · 1

Date	Issuer	Release
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.

All press releases naming this drug 14 releases

Date	Issuer	Release
2016-09-02	Novo Nordisk A/S	FDA forlænger registreringsprocessen for IDegLira med tre måneder novonordisk.com ↗
2016-09-02	Novo Nordisk A/S	FDA extends regulatory review period for IDegLira by three months novonordisk.com ↗
2016-05-24	Novo Nordisk A/S	FDA's rådgivende komite anbefaler godkendelse af IDegLira med stemmerne 16-0 novonordisk.com ↗
2016-05-24	Novo Nordisk A/S	IDegLira receives positive 16-0 vote in favour of approval from FDA Advisory Committee novonordisk.com ↗
2016-05-20	Novo Nordisk A/S	FDA offentliggør briefingmateriale forud for møde i rådgivende komite om IDegLira, en kombination af insulin degludec og liraglutid novonordisk.com ↗
2016-05-20	Novo Nordisk A/S	FDA posts briefing materials prior to Advisory Committee meeting for IDegLira, a fixed combination product of insulin degludec and liraglutide novonordisk.com ↗
2014-09-18	Novo Nordisk A/S	Xultophy® (IDegLira) approved in Europe novonordisk.com ↗
2014-09-18	Novo Nordisk A/S	Xultophy® (IDegLira) godkendt i Europa novonordisk.com ↗
2014-07-25	Novo Nordisk A/S	Novo Nordisk modtager positiv udtalelse om Xultophy® (IDegLira) fra de europæiske registreringsmyndigheder novonordisk.com ↗
2014-07-25	Novo Nordisk A/S	Novo Nordisk receives positive opinion on Xultophy® (IDegLira) from the European regulatory authorities novonordisk.com ↗
2013-05-31	Novo Nordisk A/S	Novo Nordisk indsender registreringsansøgning for IDegLira i EU til behandling af type 2-diabetes novonordisk.com ↗
2013-05-31	Novo Nordisk A/S	Novo Nordisk files for regulatory approval of IDegLira in the EU for the treatment of type 2 diabetes novonordisk.com ↗
2012-12-19	Novo Nordisk A/S	Det sidste fase 3a-studie for IDegLira afsluttet, og FIAsp godkendt til fase 3-udvikling novonordisk.com ↗
2012-12-19	Novo Nordisk A/S	The final phase 3a trial for IDegLira completed, and FIAsp approved for phase 3 development novonordisk.com ↗

Evidence & citations 4 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 NCT01618162 ↗
Known as	IDegLira	“Safety and efficacy of insulin degludec/liraglutide (IDegLira) added to sulphonylurea alone or to sulphonylurea and metformin in insulin-naïve people with Type 2 diabetes:...” PMID 27589252 ↗ Oct 2016
Modality	Other / unclassified	“AIM: To investigate the safety and efficacy of insulin degludec/liraglutide (IDegLira), a novel combination product, as add-on therapy for people with Type 2 diabetes...” PMID 27589252 ↗ Oct 2016
Route	Subcutaneous	“Injected subcutaneously (under the skin) once daily.” NCT01618162 ↗