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Published in: Drugs 8/2014

01-06-2014 | R&D Insight Report

Albiglutide: First Global Approval

Authors: Raewyn M. Poole, Mary L. Nowlan

Published in: Drugs | Issue 8/2014

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Abstract

Albiglutide (Eperzan® [EU]; Tanzeum™ [US]), a glucagon-like peptide 1 receptor agonist, has been developed by GlaxoSmithKline for the treatment of type 2 diabetes mellitus (T2DM). Albiglutide has received its first global approval in this indication in the EU, for use in combination with other antihyperglycaemic agents, including basal insulin, when these drugs and diet and exercise do not provide adequate glycaemic control, and as monotherapy in patients unable to take metformin due to contraindications or intolerance when diet and exercise alone do not provide adequate glycaemic control. Albiglutide has subsequently been approved for the second-line or later treatment of T2DM as an adjunct to diet and exercise in the US. This article summarizes the milestones in the development of albiglutide leading to this first approval for the treatment of T2DM.
Literature
1.
go back to reference Meier JJ, Nauck MA. Is the diminished incretin effect in type 2 diabetes just an epi-phenomenon of impaired beta-cell function? Diabetes. 2010;59(5):1117–25.PubMedCentralPubMedCrossRef Meier JJ, Nauck MA. Is the diminished incretin effect in type 2 diabetes just an epi-phenomenon of impaired beta-cell function? Diabetes. 2010;59(5):1117–25.PubMedCentralPubMedCrossRef
2.
go back to reference Berlie H, Hurren KM, Pinelli NR. Glucagon-like peptide-1 receptor agonists as add-on therapy to basal insulin in patients with type 2 diabetes: a systematic review. Diabetes Metab Syndr Obes. 2012;5:165–74.PubMedCentralPubMed Berlie H, Hurren KM, Pinelli NR. Glucagon-like peptide-1 receptor agonists as add-on therapy to basal insulin in patients with type 2 diabetes: a systematic review. Diabetes Metab Syndr Obes. 2012;5:165–74.PubMedCentralPubMed
3.
go back to reference Lorenz M, Evers A, Wagner M. Recent progress and future options in the development of GLP-1 receptor agonists for the treatment of diabesity. Bioorg Med Chem Lett. 2013;23(14):4011–8.PubMedCrossRef Lorenz M, Evers A, Wagner M. Recent progress and future options in the development of GLP-1 receptor agonists for the treatment of diabesity. Bioorg Med Chem Lett. 2013;23(14):4011–8.PubMedCrossRef
5.
go back to reference GlaxoSmithKline. GSK receives European authorisation for once-weekly type 2 diabetes treatment, Eperzan(Rm) (albiglutide) [media release]. 26 Mar 2014. URL. GlaxoSmithKline. GSK receives European authorisation for once-weekly type 2 diabetes treatment, Eperzan(Rm) (albiglutide) [media release]. 26 Mar 2014. URL.
11.
go back to reference Human Genome Sciences. Human Genome Sciences Announces Agreement With GlaxoSmithKline for Development and Commercialization of Novel Drug to Treat Diabetes [media release]. 26 Oct 2004. http://www.hgsi.com. Human Genome Sciences. Human Genome Sciences Announces Agreement With GlaxoSmithKline for Development and Commercialization of Novel Drug to Treat Diabetes [media release]. 26 Oct 2004. http://​www.​hgsi.​com.
14.
go back to reference Bush MA, Matthews JE, De Boever EH, et al. Safety, tolerability, pharmacodynamics and pharmacokinetics of albiglutide, a long-acting glucagon-like peptide-1 mimetic, in healthy subjects. Diabetes Obes Metab. 2009;11(5):498–505.PubMedCrossRef Bush MA, Matthews JE, De Boever EH, et al. Safety, tolerability, pharmacodynamics and pharmacokinetics of albiglutide, a long-acting glucagon-like peptide-1 mimetic, in healthy subjects. Diabetes Obes Metab. 2009;11(5):498–505.PubMedCrossRef
15.
go back to reference Baggio LL, Huang Q, Brown TJ, et al. A recombinant human glucagon-like peptide (GLP)-1-albumin protein (albugon) mimics peptidergic activation of GLP-1 receptor-dependent pathways coupled with satiety, gastrointestinal motility, and glucose homeostasis. Diabetes. 2004;53(9):2492–500.PubMedCrossRef Baggio LL, Huang Q, Brown TJ, et al. A recombinant human glucagon-like peptide (GLP)-1-albumin protein (albugon) mimics peptidergic activation of GLP-1 receptor-dependent pathways coupled with satiety, gastrointestinal motility, and glucose homeostasis. Diabetes. 2004;53(9):2492–500.PubMedCrossRef
16.
go back to reference Bao W, Aravindhan K, Alsaid H, et al. Albiglutide, a long lasting glucagon-like peptide-1 analog, protects the rat heart against ischemia/reperfusion injury: evidence for improving cardiac metabolic efficiency. PLoS ONE [Electronic Resource]. 2011;6(8):e23570.PubMedCentralPubMedCrossRef Bao W, Aravindhan K, Alsaid H, et al. Albiglutide, a long lasting glucagon-like peptide-1 analog, protects the rat heart against ischemia/reperfusion injury: evidence for improving cardiac metabolic efficiency. PLoS ONE [Electronic Resource]. 2011;6(8):e23570.PubMedCentralPubMedCrossRef
17.
go back to reference Hompesch M, Leone-Jones A, Carr MC, et al. Albiglutide does not impact the counter regulatory hormone response or recovery time from hypoglycemia in patients with type 2 diabetes (T2DM): A randomized, double-blind, placebo controlled, stepped automated glucose clamp study. Diabetes. 2013;62:A260. Hompesch M, Leone-Jones A, Carr MC, et al. Albiglutide does not impact the counter regulatory hormone response or recovery time from hypoglycemia in patients with type 2 diabetes (T2DM): A randomized, double-blind, placebo controlled, stepped automated glucose clamp study. Diabetes. 2013;62:A260.
18.
go back to reference Stewart MW, Matthews J, De Boever EH, et al. Pharmacodynamics, pharmacokinetics, safety, and tolerability of albiglutide (Syncria Rm), a long-acting GLP-1 mimetic, in subjects with type 2 diabetes. Diabetes. 2008;57(Suppl. 1):154 (plus poster) abstr. 519-P. Stewart MW, Matthews J, De Boever EH, et al. Pharmacodynamics, pharmacokinetics, safety, and tolerability of albiglutide (Syncria Rm), a long-acting GLP-1 mimetic, in subjects with type 2 diabetes. Diabetes. 2008;57(Suppl. 1):154 (plus poster) abstr. 519-P.
19.
go back to reference Seino Y, Nakajima H, Miyahara H, et al. Safety, tolerability, pharmacokinetics and pharmacodynamics of albiglutide, a long-acting GLP-1-receptor agonist, in Japanese subjects with type 2 diabetes mellitus. Curr Med Res Opin. 2009;25(12):3049–57.PubMedCrossRef Seino Y, Nakajima H, Miyahara H, et al. Safety, tolerability, pharmacokinetics and pharmacodynamics of albiglutide, a long-acting GLP-1-receptor agonist, in Japanese subjects with type 2 diabetes mellitus. Curr Med Res Opin. 2009;25(12):3049–57.PubMedCrossRef
20.
go back to reference Darpo B, Zhou M, Matthews J, et al. Albiglutide does not prolong the QTc interval in healthy subjects: A thorough QT/QTc study. Diabetes. 2013;62:A269. Darpo B, Zhou M, Matthews J, et al. Albiglutide does not prolong the QTc interval in healthy subjects: A thorough QT/QTc study. Diabetes. 2013;62:A269.
21.
go back to reference Stewart MW, Matthews J, De Boever EH, et al. Albiglutide, a long-acting GLP-1 mimetic: pharmacodynamics, pharmacokinetics, safety and tolerability in subjects with type 2 diabetes. In: 44th Annual Meeting of the European Association for the Study of Diabetes. 2008:abstr. 870. Stewart MW, Matthews J, De Boever EH, et al. Albiglutide, a long-acting GLP-1 mimetic: pharmacodynamics, pharmacokinetics, safety and tolerability in subjects with type 2 diabetes. In: 44th Annual Meeting of the European Association for the Study of Diabetes. 2008:abstr. 870.
22.
go back to reference Seino Y, Nakajima H, Miyahara H, et al. Safety and tolerability, pharmacokinetics and pharmacodynamics of albiglutide in japanese subjects with type 2 diabetes: A comparison with an ethnically mixed population. Can J Diabetes. 2009;33(3):291–2.CrossRef Seino Y, Nakajima H, Miyahara H, et al. Safety and tolerability, pharmacokinetics and pharmacodynamics of albiglutide in japanese subjects with type 2 diabetes: A comparison with an ethnically mixed population. Can J Diabetes. 2009;33(3):291–2.CrossRef
23.
go back to reference Bush MA, Smith C, Watanalumlerd P, et al. Population pharmacokinetic (PK) analysis of albiglutide in a phase iib study in Japanese patients with type 2 diabetes. Diabetes. 2012;61:A261–2. Bush MA, Smith C, Watanalumlerd P, et al. Population pharmacokinetic (PK) analysis of albiglutide in a phase iib study in Japanese patients with type 2 diabetes. Diabetes. 2012;61:A261–2.
24.
go back to reference Bush M, Scott R, Watanalumlerd P, et al. Effects of multiple doses of albiglutide on the pharmacokinetics, pharmacodynamics, and safety of digoxin, warfarin, or a low-dose oral contraceptive. Postgrad Med. 2012;124(6):55–72.PubMedCrossRef Bush M, Scott R, Watanalumlerd P, et al. Effects of multiple doses of albiglutide on the pharmacokinetics, pharmacodynamics, and safety of digoxin, warfarin, or a low-dose oral contraceptive. Postgrad Med. 2012;124(6):55–72.PubMedCrossRef
26.
go back to reference Reusch J, Stewart M, Perkins C, et al. HARMONY 1 results at week 52 primary endpoint: once-weekly albiglutide vs placebo in patients with type 2 diabetes mellitus not controlled on pioglitazone ± metformin. In: 49th Annual Meeting of the European Association for the Study of Diabetes. 2013:abstr. 902. Reusch J, Stewart M, Perkins C, et al. HARMONY 1 results at week 52 primary endpoint: once-weekly albiglutide vs placebo in patients with type 2 diabetes mellitus not controlled on pioglitazone ± metformin. In: 49th Annual Meeting of the European Association for the Study of Diabetes. 2013:abstr. 902.
27.
go back to reference Reusch J, Stewart M, Perkins C, et al. HARMONY 1 week 52 results: albiglutide vs. placebo in patients with type 2 diabetes mellitus not controlled onpioglitazone ± metformin. In: 73rd Annual Scientific Sessions of the American Diabetes Association. 2013:abstr. 57-LB. Reusch J, Stewart M, Perkins C, et al. HARMONY 1 week 52 results: albiglutide vs. placebo in patients with type 2 diabetes mellitus not controlled onpioglitazone ± metformin. In: 73rd Annual Scientific Sessions of the American Diabetes Association. 2013:abstr. 57-LB.
28.
go back to reference Nauck M, Stewart M, Perkins C, et al. HARMONY 2 Wk 52 Results: Albiglutide Monotherapy in Drug Naive Patients with Type 2 Diabetes Mellitus. In: 73rd Annual Scientific Sessions of the American Diabetes Association. 2013:abstr. 55-LB. Nauck M, Stewart M, Perkins C, et al. HARMONY 2 Wk 52 Results: Albiglutide Monotherapy in Drug Naive Patients with Type 2 Diabetes Mellitus. In: 73rd Annual Scientific Sessions of the American Diabetes Association. 2013:abstr. 55-LB.
29.
go back to reference Reinhardt R, Nauck MA, Stewart M, et al. HARMONY 2 results at week 52 primary endpoint: once-weekly albiglutide monotherapy for patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. In: 49th Annual Meeting of the European Association for the Study of Diabetes. 2013:abstr. 903. Reinhardt R, Nauck MA, Stewart M, et al. HARMONY 2 results at week 52 primary endpoint: once-weekly albiglutide monotherapy for patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. In: 49th Annual Meeting of the European Association for the Study of Diabetes. 2013:abstr. 903.
30.
go back to reference Ahren B, Stewart M, Cirkel D, et al. HARMONY 3: 104 Week (Wk) Efficacy of Albiglutide (Albi) Compared to Sitagliptin (Sita) and Glimepiride (SU) in Patients (pts) with Type 2 Diabetes Mellitus (T2DM) on Metformin (Met). In: 73rd Annual Scientific Sessions of the American Diabetes Association. 2013:abstr. 52-LB. Ahren B, Stewart M, Cirkel D, et al. HARMONY 3: 104 Week (Wk) Efficacy of Albiglutide (Albi) Compared to Sitagliptin (Sita) and Glimepiride (SU) in Patients (pts) with Type 2 Diabetes Mellitus (T2DM) on Metformin (Met). In: 73rd Annual Scientific Sessions of the American Diabetes Association. 2013:abstr. 52-LB.
31.
go back to reference Johnson S, Ahren B, Stewart M, et al. HARMONY 3: 104 week efficacy of albiglutide compared to sitagliptin and glimepiride in patients with type 2 diabetes mellitus on metformin. In: 49th Annual Meeting of the European Association for the Study of Diabetes. 2013:abstr. 5. Johnson S, Ahren B, Stewart M, et al. HARMONY 3: 104 week efficacy of albiglutide compared to sitagliptin and glimepiride in patients with type 2 diabetes mellitus on metformin. In: 49th Annual Meeting of the European Association for the Study of Diabetes. 2013:abstr. 5.
32.
go back to reference Pratley R, Stewart M, Cirkel D, et al. HARMONY 4: 52-week efficacy of albiglutide vs insulin glargine in patients with type 2 diabetes mellitus. In: 49th Annual Meeting of the European Association for the Study of Diabetes. 2013:abstr. 904. Pratley R, Stewart M, Cirkel D, et al. HARMONY 4: 52-week efficacy of albiglutide vs insulin glargine in patients with type 2 diabetes mellitus. In: 49th Annual Meeting of the European Association for the Study of Diabetes. 2013:abstr. 904.
33.
go back to reference Home P, Stewart M, Yang F. 52-week efficacy of albiglutide vs placebo and vs pioglitazone in triple therapy (background metformin and glimepiride) in people with type 2 diabetes: HARMONY5 Study. In: 73rd Annual Scientific Sessions of the American Diabetes Association. 2013:abstr. 58-LB. Home P, Stewart M, Yang F. 52-week efficacy of albiglutide vs placebo and vs pioglitazone in triple therapy (background metformin and glimepiride) in people with type 2 diabetes: HARMONY5 Study. In: 73rd Annual Scientific Sessions of the American Diabetes Association. 2013:abstr. 58-LB.
34.
go back to reference Fonseca VL, Ahren B, Chow F, et al. Once weekly GLP-1 receptor agonist albiglutide vs prandial lispro added to basal glargine in type 2 diabetes: similar glycaemic control with weight loss and less hypoglycaemia. Diabetologia. 2012;55:S241. Fonseca VL, Ahren B, Chow F, et al. Once weekly GLP-1 receptor agonist albiglutide vs prandial lispro added to basal glargine in type 2 diabetes: similar glycaemic control with weight loss and less hypoglycaemia. Diabetologia. 2012;55:S241.
35.
go back to reference Rosenstock J, Ahren B, Chow F, et al. Once-weekly GLP-1 receptor agonist Albiglutide vs. Titrated prandial lispro added on to titrated basal insulin glargine in Type 2 Diabetes (T2D) uncontrolled on glargine plus oral agents: Similar glycemic control with weight loss and less hypoglycemia. Diabetes. 2012;61:A15–6.CrossRef Rosenstock J, Ahren B, Chow F, et al. Once-weekly GLP-1 receptor agonist Albiglutide vs. Titrated prandial lispro added on to titrated basal insulin glargine in Type 2 Diabetes (T2D) uncontrolled on glargine plus oral agents: Similar glycemic control with weight loss and less hypoglycemia. Diabetes. 2012;61:A15–6.CrossRef
36.
go back to reference Pratley RE, Barnett A, Feinglos MM, et al. Efficacy and safety of once-weekly (QW) albiglutide vs. once-daily (QD) liraglutide in type 2 diabetes (T2D) inadequately controlled on oral agents: Harmony 7 trial. Diabetes. 2012;61:A240–1. Pratley RE, Barnett A, Feinglos MM, et al. Efficacy and safety of once-weekly (QW) albiglutide vs. once-daily (QD) liraglutide in type 2 diabetes (T2D) inadequately controlled on oral agents: Harmony 7 trial. Diabetes. 2012;61:A240–1.
37.
go back to reference Leiter LA, Carr MC, Stewart M, et al. Harmony 8: Once weekly (QW) GLP1 Agonist Albiglutide (Albi) vs. Sitagliptin (Sita) in Type 2 Diabetes (T2D) Pts With Renal Impairment (RI): Week 26 Results. Diabetes. 2013;62:A17. Leiter LA, Carr MC, Stewart M, et al. Harmony 8: Once weekly (QW) GLP1 Agonist Albiglutide (Albi) vs. Sitagliptin (Sita) in Type 2 Diabetes (T2D) Pts With Renal Impairment (RI): Week 26 Results. Diabetes. 2013;62:A17.
38.
go back to reference Martin AA, Johnson SL, Ye J, et al. Improved treatment satisfaction with weekly abiglutide vs. Thrice daily prandial insulin added to insulin glargine in type 2 diabetes. Diabetes. 2013;62:A659. Martin AA, Johnson SL, Ye J, et al. Improved treatment satisfaction with weekly abiglutide vs. Thrice daily prandial insulin added to insulin glargine in type 2 diabetes. Diabetes. 2013;62:A659.
39.
go back to reference Pratley RE, Nauck MA, Barnett AH, et al. Once-weekly albiglutide versus once-daily liraglutide in patients with type 2 diabetes inadequately controlled on oral drugs (HARMONY 7): a randomised, open-label, multicentre, non-inferiority phase 3 study. Lancet Diabetes Endocrinol. 2014;2(4):289–97.PubMedCrossRef Pratley RE, Nauck MA, Barnett AH, et al. Once-weekly albiglutide versus once-daily liraglutide in patients with type 2 diabetes inadequately controlled on oral drugs (HARMONY 7): a randomised, open-label, multicentre, non-inferiority phase 3 study. Lancet Diabetes Endocrinol. 2014;2(4):289–97.PubMedCrossRef
40.
go back to reference Martin AA, Johnson SL, Ye J, et al. Treatment satisfaction with albiglutide and liraglutide in patients with type 2 diabetes uncontrolled with oral therapy. Diabetes. 2013;62:A259–60. Martin AA, Johnson SL, Ye J, et al. Treatment satisfaction with albiglutide and liraglutide in patients with type 2 diabetes uncontrolled with oral therapy. Diabetes. 2013;62:A259–60.
42.
go back to reference Rosenstock J, Reusch J, Bush M, et al. Potential of albiglutide, a long-acting GLP-1 receptor agonist, in type 2 diabetes: a randomized controlled trial exploring weekly, biweekly, and monthly dosing. Diabetes Care. 2009;32:1880–6.PubMedCentralPubMedCrossRef Rosenstock J, Reusch J, Bush M, et al. Potential of albiglutide, a long-acting GLP-1 receptor agonist, in type 2 diabetes: a randomized controlled trial exploring weekly, biweekly, and monthly dosing. Diabetes Care. 2009;32:1880–6.PubMedCentralPubMedCrossRef
43.
go back to reference Seino Y, Inagaki N, Miyahara H, et al. Albiglutide significantly lowers glycemia in japanese patients with type 2 diabetes (T2D). Diabetes. 2012;61:A248. Seino Y, Inagaki N, Miyahara H, et al. Albiglutide significantly lowers glycemia in japanese patients with type 2 diabetes (T2D). Diabetes. 2012;61:A248.
Metadata
Title
Albiglutide: First Global Approval
Authors
Raewyn M. Poole
Mary L. Nowlan
Publication date
01-06-2014
Publisher
Springer International Publishing
Published in
Drugs / Issue 8/2014
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-014-0228-2

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