Albiglutide: First global approval

Drugs

Volumn 74, Issue 8, 2014, Pages 929-938

  Poole, Raewyn M ^b   Nowlan, Mary L ^a  

^a Adis R and D Insight   (New Zealand)

^b ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

2,4 THIAZOLIDINEDIONE DERIVATIVE; ALBIGLUTIDE; ALPHA GLUCOSIDASE INHIBITOR; ANTIDIABETIC AGENT; BIGUANIDE DERIVATIVE; DIGOXIN; ETHINYLESTRADIOL PLUS NORETHISTERONE; EXENDIN 4; GLIMEPIRIDE; HEMOGLOBIN A1C; INSULIN; INSULIN GLARGINE; INSULIN LISPRO; LIRAGLUTIDE; MEGLITINIDE; METFORMIN; MOXIFLOXACIN; NORETHISTERONE; PIOGLITAZONE; PLACEBO; SIMVASTATIN; SITAGLIPTIN; SULFONYLUREA; WARFARIN; GLUCAGON LIKE PEPTIDE 1; GLUCAGON RECEPTOR; GLUCAGON-LIKE PEPTIDE-1 RECEPTOR; RGLP-1 PROTEIN;

AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BODY WEIGHT; CARDIOVASCULAR EFFECT; CLINICAL TRIAL (TOPIC); DIABETIC PATIENT; DIARRHEA; DRUG APPROVAL; DRUG EFFICACY; DRUG HALF LIFE; DRUG INDUSTRY; DRUG POTENTIATION; DRUG SAFETY; GLYCEMIC CONTROL; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; MAXIMUM PLASMA CONCENTRATION; MONOTHERAPY; MULTICENTER STUDY (TOPIC); NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; ORAL CONTRACEPTIVE USE; PATIENT SATISFACTION; PHARMACODYNAMICS; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK REDUCTION; TIME TO MAXIMUM PLASMA CONCENTRATION; UPPER RESPIRATORY TRACT INFECTION; AGONISTS; ANALOGS AND DERIVATIVES; ANIMAL; DIABETES MELLITUS, TYPE 2; DRUG COMBINATION;

ANIMALS; DIABETES MELLITUS, TYPE 2; DRUG APPROVAL; DRUG THERAPY, COMBINATION; GLUCAGON-LIKE PEPTIDE 1; HUMANS; HYPOGLYCEMIC AGENTS; RECEPTORS, GLUCAGON;

EID: 84902251849     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.1007/s40265-014-0228-2     Document Type: Article

References (45)

1. 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.
2. 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.
3. 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.
4. European Medicines Agency. EPAR summary for the public: Eperzan albiglutide. http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product- Information/human/002735/WC500165117.pdf. Accessed 10 April 201.
5. GlaxoSmithKline. GSK receives European authorisation for once-weekly type 2 diabetes treatment, Eperzan(Rm) (albiglutide) [media release]. 26 Mar 2014. URL.
6. European Medicines Agency. Eperzan: EPAR - Product Information. http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/ human/002735/WC500165117.pdf. Accessed 10 April 2014.
7. European Medicines Agency. Summary of the risk management plan (RMP) for Eperzan (albiglutide). http://www.ema.europa.eu/docs/en-GB/document-library/ EPAR-Risk-management-plan-summary/human/002735/WC50016258pdf. Accessed 10 April 2014.
8. US Food and Drug Administration. FDA approves Tanzeum to treat type 2 diabetes [media release]. 15 April 2014. http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm393289.htm.
9. GlaxoSmithKline. TANZEUM Prescribing Information. https://www.gsksource. com/gskprm/htdocs/documents/TANZEUM-PI-MG-IFU-COMBINED.PDF. Accessed 8 May 2014.
10. US Food and Drug Administration. BLA STN-125431 TANZEUM™ (Albiglutide). Glucagon-like Peptide-1 (GLP-1) Receptor Agonist, GlaxoSmithKline LLC. RISK EVALUATION AND MITIGATION STRATEGY (REMS). http://www.fda.gov/ downloads/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/UCM393986.pdf. Accessed 8 May 2014.
11. 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.
12. GlaxoSmithKline. GSK Completes Acquisition of Human Genome Sciences [media release]. 3 Aug 20 http://www.gsk.com.
13. Novozymes. Novozymes technology enables GlaxoSmithKline's new once-weekly diabetes treatment [media release]. 31 March 2014. http://novozymes.com/en/ news/news-archive/Pages/Novozymes-technology-enables-GlaxoSmithKline's-new-once- weekly-diabetes-treatment.aspx.
14. 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.
15. 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.
16. 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.
17. 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. 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. 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.
20. 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. 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. 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.
23. 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. 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.
25. GlaxoSmithKline. An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects. 2011. http://www.gsk-clinicalstudyregister.com/study/108366#ps. Accessed 2014.
26. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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.
36. 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. 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. 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. 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.
40. 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.
41. GlaxoSmithKline. A randomized, double-blind, active-controlled, parallel-group, multicenter study to determine the efficacy and safety of albiglutide as compared with sitagliptin in subjects with type 2 diabetes mellitus with renal impairment. http://www.gsk-clinicalstudyregister.com/study/ 114130#rs. Accessed 08 May 2014.
42. 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.
43. Seino Y, Inagaki N, Miyahara H, et al. Albiglutide significantly lowers glycemia in japanese patients with type 2 diabetes (T2D). Diabetes. 2012;61:A248.
44. GlaxoSmithKline. A monotherapy study to evaluate the efficacy and safety of 2 dose levels of albiglutide in japanese subjects with type 2 diabetes mellitus (T2DM) [ClinicalTrials.gov identifier NCT01733758] US National Institutes of Health, ClinicalTrials.gov. http://www.clinicaltrials.gov/ct2/ show/NCT01733758?term=NCT01733758&rank=1. Accessed 15 April 2014.
45. GlaxoSmithKline. A Study to Determine the Long Term Safety and Efficacy of Albiglutide in Combination With Oral Monotherapy Antihyperglycemic Medications in Japanese Patients With Type 2 Diabetes Mellitus [ClinicalTrials.gov identifier NCT01777282] US National Institutes of Health, ClinicalTrials.gov. http://www.clinicaltrials.gov/ct2/show/NCT01777282?term= NCT01777282&rank=1. Accessed 15 April 2014.