insulin degludec/insulin aspart

also known as IDegAsp

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	US (FDA)	Ryzodeg	diabetes mellitus	2015-04-07	“FDA) has accepted for review the Class II Resubmissions for Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart).” novonordisk.com ↗
Rejected (CRL)	US (FDA)	Ryzodeg	diabetes mellitus	2013-02-08	“Complete Response Letter from the US Food and Drug Administration (FDA) regarding the New Drug Applications for Tresiba® (insulin degludec) and Ryzodeg® (insulin...” novonordisk.com ↗

Trials 1

today NCT00613951 · Ph 2

20082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 2	NCT00613951	Jan → Aug 2008	type 2 diabetes mellitus	Novo Nordisk A/S	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 18

Date	Issuer	Release
2015-09-25	Novo Nordisk A/S	Regulatory Novo Nordisk får FDA-godkendelse for Tresiba® og Ryzodeg® 70/30 i USA novonordisk.com ↗ Bagsværd, den 25. september 2015 - Novo Nordisk meddeler i dag, at de amerikanske sundhedsmyndigheder (FDA) efter at have afsluttet behandlingen af de genindsendte registreringsansøgninger har godkendt Tresiba® og Ryzodeg® 70/30 til behandling af diabetes hos voksne.
2015-09-25	Novo Nordisk A/S	Regulatory Novo Nordisk receives US FDA approval for Tresiba® and Ryzodeg® 70/30 novonordisk.com ↗ Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Tresiba® and Ryzodeg® 70/30 for the treatment of diabetes mellitus in adults after review of the class II resubmissions of the New Drug Applications (NDAs).
2015-04-07	Novo Nordisk A/S	Regulatory Novo Nordisk A/S: Amerikanske FDA accepterer at behandle genindsendelserne af Tresiba® og Ryzodeg® novonordisk.com ↗ Novo Nordisk meddeler i dag, at de amerikanske sundhedsmyndigheder (FDA) har accepteret de genindsendte registreringsansøgninger for Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart) til behandling som en 'Class II Resubmission'.
2015-04-07	Novo Nordisk A/S	Regulatory US FDA accepts Tresiba® and Ryzodeg® resubmissions for review novonordisk.com ↗ Novo Nordisk today announced that the US Food and Drug Administration (FDA) has accepted for review the Class II Resubmissions for Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart).
2013-02-10	Novo Nordisk A/S	Regulatory Novo Nordisk receives Complete Response Letter in the US for Tresiba® and Ryzodeg® novonordisk.com ↗ Novo Nordisk today announced that on 8 February 2013 it received a Complete Response Letter from the US Food and Drug Administration (FDA) regarding the New Drug Applications for Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart).
2013-02-10	Novo Nordisk A/S	Regulatory Novo Nordisk modtager Complete Response Letter i USA vedrørende Tresiba® og Ryzodeg® novonordisk.com ↗ Novo Nordisk meddeler i dag, at virksomheden den 8. februar 2013 har modtaget et såkaldt Complete Response Letter fra de amerikanske sundhedsmyndigheder, FDA, vedrørende registreringsansøgningerne for Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart).
2013-01-21	Novo Nordisk A/S	Regulatory Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart) får markedsføringstilladelse i Europa novonordisk.com ↗ Bagsværd, den 21. januar 2013 - Novo Nordisk meddelte i dag, at Europa-Kommissionen har givet markedsføringstilladelse til Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart) til behandling af diabetes hos voksne.
2013-01-21	Novo Nordisk A/S	Regulatory Tresiba® and Ryzodeg® receive marketing authorisations in Europe novonordisk.com ↗ Novo Nordisk today announced that the European Commission has granted marketing authorisations for Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart) for the treatment of diabetes in adults.
2012-12-25	Novo Nordisk A/S	Regulatory Ryzodeg® (insulin degludec/insulin aspart) approved in Japan novonordisk.com ↗ Novo Nordisk today announced that the Japanese Ministry of Health, Labour and Welfare has approved Ryzodeg® (insulin degludec/insulin aspart) for the treatment of diabetes.
2012-12-25	Novo Nordisk A/S	Regulatory Ryzodeg® (insulin degludec/insulin aspart) godkendt i Japan novonordisk.com ↗ Bagsværd, den 25. december 2012 - Novo Nordisk meddelte i dag, at det japanske ministerium for sundhed, arbejde og velfærd har godkendt Ryzodeg® (insulin degludec/insulin aspart) til behandling af diabetes.
2012-12-03	Novo Nordisk A/S	Regulatory Ryzodeg® (insulin degludec/insulin aspart) passed review by First Committee on Drugs of Pharmaceutical Affairs in Japan novonordisk.com ↗ Novo Nordisk today announced that Ryzodeg® (insulin degludec/insulin aspart) has passed the review by the First Committee on Drugs of Japan's Pharmaceutical Affairs.
2012-12-03	Novo Nordisk A/S	Regulatory Ryzodeg® (insulin degludec/insulin aspart) passerer evaluering i japansk medicinkomite novonordisk.com ↗ Novo Nordisk meddelte i dag, at Ryzodeg® (insulin degludec/insulin aspart) har passeret evalueringen i en medicinsk komite under de japanske sundhedsmyndigheder, First Committee on Drugs of Japan's Pharmaceutical Affairs.
2012-11-08	Novo Nordisk A/S	Regulatory Positiv afstemning i FDA's rådgivende komite vedrørende godkendelse af insulin degludec og insulin degludec/ insulin aspart novonordisk.com ↗
2012-11-08	Novo Nordisk A/S	Regulatory Insulin degludec and insulin degludec/insulin aspart receive positive vote for approval from FDA Advisory Committee novonordisk.com ↗
2012-07-18	Novo Nordisk A/S	Regulatory Novo Nordisk A/S: FDA berammer møde i rådgivende komite om insulin degludec og insulin degludec/insulin aspart novonordisk.com ↗ Novo Nordisk meddelte i dag, at de amerikanske sundhedsmyndigheder, FDA, har oplyst, at man vil afholde et møde i FDA's rådgivende komite, hvor registreringsansøgningerne for ultralangtidsvirkende insulin degludec og insulin degludec/insulin aspart vil blive drøftet.
2012-07-18	Novo Nordisk A/S	Regulatory Novo Nordisk A/S: FDA schedules Advisory Committee meeting for insulin degludec and insulin degludec/insulin aspart novonordisk.com ↗ an FDA Advisory Committee meeting is tentatively scheduled to be held on 8 November 2012
2012-06-08	Novo Nordisk A/S	Regulatory Novo Nordisk A/S: FDA forlænger registreringssprocessen for insulin degludec og insulin degludec/insulin aspart med tre måneder novonordisk.com ↗ Novo Nordisk har i dag meddelt, at de amerikanske sundhedsmyndigheder (FDA) har forlænget registreringssprocessen for den ultralangtidsvirkende insulin degludec og insulin degludec/insulin aspart til behandling af type 1- og type 2-diabetes.
2012-06-08	Novo Nordisk A/S	Regulatory Novo Nordisk A/S: FDA extends regulatory review period for insulin degludec and insulin degludec/insulin aspart by three months novonordisk.com ↗ Novo Nordisk today announced that the US Food and Drug Administration (FDA) has extended the regulatory review period for the ultra-long-acting insulins degludec and insulin degludec/insulin aspart for the treatment of type 1 and type 2 diabetes.

All press releases naming this drug 24 releases

Date	Issuer	Release
2015-09-25	Novo Nordisk A/S	Novo Nordisk får FDA-godkendelse for Tresiba® og Ryzodeg® 70/30 i USA novonordisk.com ↗
2015-09-25	Novo Nordisk A/S	Novo Nordisk receives US FDA approval for Tresiba® and Ryzodeg® 70/30 novonordisk.com ↗
2015-04-07	Novo Nordisk A/S	Novo Nordisk A/S: Amerikanske FDA accepterer at behandle genindsendelserne af Tresiba® og Ryzodeg® novonordisk.com ↗
2015-04-07	Novo Nordisk A/S	US FDA accepts Tresiba® and Ryzodeg® resubmissions for review novonordisk.com ↗
2013-02-10	Novo Nordisk A/S	Novo Nordisk receives Complete Response Letter in the US for Tresiba® and Ryzodeg® novonordisk.com ↗
2013-02-10	Novo Nordisk A/S	Novo Nordisk modtager Complete Response Letter i USA vedrørende Tresiba® og Ryzodeg® novonordisk.com ↗
2013-01-21	Novo Nordisk A/S	Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart) får markedsføringstilladelse i Europa novonordisk.com ↗
2013-01-21	Novo Nordisk A/S	Tresiba® and Ryzodeg® receive marketing authorisations in Europe novonordisk.com ↗
2012-12-25	Novo Nordisk A/S	Ryzodeg® (insulin degludec/insulin aspart) approved in Japan novonordisk.com ↗
2012-12-25	Novo Nordisk A/S	Ryzodeg® (insulin degludec/insulin aspart) godkendt i Japan novonordisk.com ↗
2012-12-03	Novo Nordisk A/S	Ryzodeg® (insulin degludec/insulin aspart) passed review by First Committee on Drugs of Pharmaceutical Affairs in Japan novonordisk.com ↗
2012-12-03	Novo Nordisk A/S	Ryzodeg® (insulin degludec/insulin aspart) passerer evaluering i japansk medicinkomite novonordisk.com ↗
2012-11-08	Novo Nordisk A/S	Positiv afstemning i FDA's rådgivende komite vedrørende godkendelse af insulin degludec og insulin degludec/ insulin aspart novonordisk.com ↗
2012-11-08	Novo Nordisk A/S	Insulin degludec and insulin degludec/insulin aspart receive positive vote for approval from FDA Advisory Committee novonordisk.com ↗
2012-11-06	Novo Nordisk A/S	FDA offentliggør briefingmateriale forud for mødet i den rådgivende komite om insulin degludec og insulin degludec/insulin aspart novonordisk.com ↗
2012-11-06	Novo Nordisk A/S	FDA posts briefing materials prior to Advisory Committee meeting for insulin degludec and insulin degludec/insulin aspart novonordisk.com ↗
2012-10-25	Novo Nordisk A/S	FDA offentliggør fokus for mødet i den rådgivende komite om insulin degludec og insulin degludec/insulin aspart novonordisk.com ↗
2012-10-25	Novo Nordisk A/S	FDA discloses focus of Advisory Committee meeting on insulin degludec and insulin degludec/insulin aspart novonordisk.com ↗
2012-10-19	Novo Nordisk A/S	Novo Nordisk modtager positive udtalelser om Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart) fra de europæiske registreringsmyndigheder novonordisk.com ↗
2012-10-19	Novo Nordisk A/S	Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart) receive positive opinions from the European regulatory authorities novonordisk.com ↗
2012-07-18	Novo Nordisk A/S	Novo Nordisk A/S: FDA berammer møde i rådgivende komite om insulin degludec og insulin degludec/insulin aspart novonordisk.com ↗
2012-07-18	Novo Nordisk A/S	Novo Nordisk A/S: FDA schedules Advisory Committee meeting for insulin degludec and insulin degludec/insulin aspart novonordisk.com ↗
2012-06-08	Novo Nordisk A/S	Novo Nordisk A/S: FDA forlænger registreringssprocessen for insulin degludec og insulin degludec/insulin aspart med tre måneder novonordisk.com ↗
2012-06-08	Novo Nordisk A/S	Novo Nordisk A/S: FDA extends regulatory review period for insulin degludec and insulin degludec/insulin aspart by three months novonordisk.com ↗

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 3 sources stand behind the page.

Field	Value	Cited text
Known as	insulin degludec/insulin aspart	ClinicalTrials.gov intervention name — accepted as the source's own label NCT00613951 ↗
Known as	IDegAsp	“OBJECTIVE: Insulin degludec/insulin aspart (IDegAsp) is a soluble co-formulation of insulin degludec (70%) and insulin aspart (IAsp: 30%).” PMID 22660026 ↗ Jun 2012
Modality	Protein / enzyme biologic	“IDegAsp , a novel soluble combination was developed with rapid-acting insulin aspart and a new-generation ultra-long-acting insulin, insulin degludec” PMID 22946603 ↗ Sep 2012