EMA Approves Awiqli®, the World’s First Once-Weekly Basal Insulin, for Treatment of Adults with Diabetes

May 24, 2024 17:18 CST Updated 18:35

Novo Nordisk

Insulin Developer and Manufacturer

• European Medicines Agency Approves Weekly for the First TimeInjectionOnce-daily basal insulin reduces the frequency of basal insulin injections from 7 times per week to once.1

• Approval based on ONWARDSPhase 3a Clinical TrialSafetySexAndEffectivenessData2-7

• Awiqli®HavePotential to Become Initial Insulin Therapy for Type 2 DiabetesThe Preferred Choice

Novo NordiskNovo NordiskRecently announced, EuAllianceThe Committee (EC) has givenAwiqli®(Basal Insulin Weekly FormulationDependKeInsulin（insulin icodec）) Marketing authorization for the treatment of adult patients with diabetes.This marketing authorization is valid in all 27 European Union (EU) member states.AndIceland, Norway andLiechtenstein。

50% of those requiring insulin treatmentType 2 DiabetesPatients delay more than 2 years before initiating insulin.8-10. Injection burden is a factor affecting patients with type 2 diabetesInsulin Treatment AdherenceMain Barriers to Initiating Insulin Therapy with DoctorsOne of 11,12。

In Phase 3a clinical trials,Compared with daily injectable basal insulin, the weekly basal insulin formulationKeInsulin inAchieved better blood glucose reduction in patients with type 2 diabetes(InHbA1cChange Measurement)2,4， Compared with insulin glargineCompared to U100InType 2 DiabetesAmong patientsHaveBetter“Time in Range（3.9-10.0 mmol/L）2. InPreviously notHave received insulin treatmentIn patients with type 2 diabetes, the weekly basal insulin formulationKeInsulin Treatment Group and Control GroupCompared with，AverageThe overall incidence of clinically significant hypoglycemia and severe hypoglycemia observed was lower than1 Event/Per PatientExposure Year 2,4,6。

Novo NordiskNovo NordiskCompanySaid: "IThemUnderstandDaily InjectionChinaThe burden caused by many patients with type 2 diabetes. We continueFocus on R&D innovation,In a new way to help people with diabetes more freely, moreGoodTo control blood sugar,At the same timeReduce the burden. As the world's first basal insulinWeekly formulation，Awiqli®It is insulin.TreatmentThe latest innovative achievements，By injecting basal insulinFrequencyReduced from 7 times a week to once a week, we believe in it.WillToPatients with diabetesWith Healthcare ProfessionalsScholarBring significant impact and improve the treatment and management model of diabetes.”

Novo NordiskNovo NordiskAlreadyIn Switzerland and CanadaObtainedAwiqli®Used for treatmentAdultType 1 and Type 2 DiabetesListedApproval.This new drug is Novo NordiskNovo NordiskThe innovative achievement of completing clinical trials simultaneously in China, the EU, and the US for the first time, and submitting new drug marketing applications concurrently.

*DependKeInsulin has not yet been approved for marketing in China.

About Awiqli®

Awiqli®（Basal Insulin WeekPreparationIcodec Insulin) is a new type of weeklyInjectionOnce-daily basal insulin analog,Designed toOne weekOneSubcutaneous injectionThat's all.MeetOneWholeWeekBasal insulin requirements，Approved for adult diabetesPatient。

AboutONWARDSClinical Research Project

TargetingBasal Insulin Weekly FormulationDependKeONWARDS with InsulinClinical ResearchProject, including 6GlobalPhase 3a clinical trial, one of whichIncludingReal-World StudyElement, enrolling over 4,000 adult patients with type 1 or type 2 diabetes.All TrialsAverageReachAchievementThe primary endpoint2-7。

References

1.Philis-Tsimikas A, Bajaj HS, Begtrup K, et al.Rationale and design of the phase 3a development programme (ONWARDS 1-6 trials) investigating once-weekly insulin icodec in diabetes. Diabetes Obes Metab. 2023;25:331-341.

2.Rosenstock J, Bain SC, Gowda A, et al. Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin. N Engl J Med. 2023;389:297-308.

3.Philis-Tsimikas A, Asong M, Franek E, et al.Switching to once-weekly insulin icodec versus once-daily insulin degludec in individuals with basal insulin-treated type 2 diabetes (ONWARDS 2): a phase 3a, randomised, open label, multicentre, treat-to-target trial. Lancet Diabetes Endocrinol. 2023;11:414-425.

4.Lingvay I, Asong M, Desouza C, et al. Once-Weekly Insulin Icodec vs Once-Daily Insulin Degludec in Adults With Insulin-Naive Type 2 Diabetes: The ONWARDS 3 Randomized Clinical Trial. JAMA. 2023;330:228-237.

5.Mathieu C, Asbjornsdottir B, Bajaj HS, et al.Switching to once-weekly insulin icodec versus once-daily insulin glargine U100 in individuals with basal-bolus insulin-treated type 2 diabetes (ONWARDS 4): a phase 3a, randomised, open-label, multicentre, treat-to-target, non-inferiority trial. Lancet. 2023;401:1929-1940.

6.Bajaj HS, Aberle J, Davies M, et al. Once-Weekly Insulin Icodec With Dosing Guide App Versus Once-Daily Basal Insulin Analogues in Insulin-Naive Type 2 Diabetes (ONWARDS 5) : A Randomized Trial. Ann Intern Med. 2023;176:1476-1485.

7.Russell-Jones D, Babazono T, Cailleteau R, et al.Once-weekly insulin icodec versus once-daily insulin degludec as part of a basal-bolus regimen in individuals with type 1 diabetes (ONWARDS 6): a phase 3a, randomised, open-label, treat-to-target trial. Lancet. 2023;402:1636-1647.

8.Novo Nordisk. Importance of initiation and titration. Company investor presentation, 2020.

9.Rubino A, McQuay LJ, Gough SC, et al. Delayed initiation of subcutaneous insulin therapy after failure of oral glucose-lowering agents in patients with Type 2 diabetes: a population-based analysis in the UK. Diabet Med. 2007;24:1412-8.

10.Hosomura N, Malmasi S, Timerman D, et al.Decline of insulin therapy and delays in insulin initiation in people with uncontrolled diabetes mellitus. Diabet Med. 2017;34:1599-1602.

11.Peyrot M, Barnett AH, Meneghini LF, et al.Insulin adherence behaviours and barriers in the multinational Global Attitudes of Patients and Physicians in Insulin Therapy study. Diabet Med. 2012;29:682-9.

12.LAI 287 Prescription and Preference Driver 2019. Base: All patients (n = 391). Markets: USA, UK, France, Germany, China and Japan.

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