Registration trials for specific immunotherapy in Europe: Advanced guidance from the new European Medical Agency guideline

Allergy: European Journal of Allergy and Clinical Immunology

Volumn 65, Issue 12, 2010, Pages 1499-1505

  Godicke V ^a   Hundt, F ^a  

^a UNIVERSITY OF DUISBURG ESSEN   (Germany)

Author keywords

Allergen products; Clinical trials; Regulatory affairs

Indexed keywords

ALLERGIC DISEASE; ALLERGIC RHINITIS; ASTHMA; CLINICAL DEVELOPMENT PLAN; EUROPEAN MEDICAL AGENCY GUIDELINE; HUMAN; IMMUNOTHERAPY; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; RHINOCONJUNCTIVITIS;

ALLERGENS; CLINICAL TRIALS AS TOPIC; DESENSITIZATION, IMMUNOLOGIC; EUROPE; HUMANS; HYPERSENSITIVITY; PRACTICE GUIDELINES AS TOPIC;

EID: 78349232770     PISSN: 01054538     EISSN: 13989995     Source Type: Journal    
DOI: 10.1111/j.1398-9995.2010.02436.x     Document Type: Review

References (38)

1. Bousquet J, Lockey R, Malling HJ,. Allergen immunotherapy: therapeutic vaccines for allergic diseases. A WHO position paper. J Allergy Clin Immunol 1998; 102: 558 -562.
2. Malling H, Weeke B,. Position paper: immunotherapy. (EAACI) The European Academy of Allergology and Clinical Immunology. Allergy 1993; 48: 7 -35.
3. Jutel M, Akdis M, Blaser K, Akdis CA,. Mechanisms of allergen specific immunotherapy-T-cell tolerance and more. Allergy 2006; 61: 796 -807. (Pubitemid 43893981)
4. Committee for Proprietary Medicinal Products (CPMP) and Biotechnology Working Party (BWP): Guideline on allergen products. production and quality issues; CPMP/EMEA/BWP/304831/2007. 2008.
5. Norman PS,. Immunotherapy: past and present. J Allergy Clin Immunol 1998; 102: 1 -10.
6. Tari MG, Mancino M, Ghezzi E, Frank E, Cromwell O,. Immunotherapy with an alum-adsorbed Parietaria-pollen allergoid: a 2-year, double-blind, placebo-controlled study. Allergy 1997; 52: 65 -74.
7. Lorenz AR, Luttkopf D, Seitz R, Vieths S,. The regulatory system in europe with special emphasis on allergen products. Int Arch Allergy Immunol 2008; 147: 263 -275.
8. Committee for Medicinal Products for Human Use (CHMP) and Efficacy Working Party (EWP): Concept Paper on the preparation of a guideline on the clinical development of products for specific immunotherapy for the treatment of allergic diseases; EMEA/CHMP/EWP/18504/2006. 2006.
9. Valenta R, Ball T, Focke M, Linhart B, Mothes N, Niederberger V, etal. Immunotherapy of allergic disease. Adv Immunol 2004; 82: 105 -153.
10. Malling HJ, Abreu-Nogueira J, Alvarez-Cuesta E, Bjorksten B, Bousquet J, Caillot D, etal. Local immunotherapy. Allergy 1998; 53: 933 -944.
11. Carnes J, Robinson DS,. New strategies for allergen immunotherapy. Recent Pat Inflamm Allergy Drug Discov 2008; 2: 92 -101.
12. Wilson DR, Lima MT, Durham SR,. Sublingual immunotherapy for allergic rhinitis: systematic review and meta-analysis. Allergy 2005; 60: 4 -12.
13. Committee for Medicinal Products for Human Use (CHMP) and Efficacy Working Party (EWP): Guideline on the clinical development of medicinal products for the treatment of allergic rhino-conjunctivitis; CHMP/EWP/2455/02. 2004.
14. Committee for Proprietary Medicinal Products (CPMP) and Efficacy Working Party (EWP): Note for Guidance on the clinical investigation of medicinal Products in the treatment of asthma; CPMP/EWP/2922/01. 2002.
15. Directive 2001/82/EC of the European Parliament and the Council on the Community code relating to medicinal products for human use. OJ 2004; 311: 67 -122.
16. Committee for Proprietary Medicinal Products (CPMP) and Biotechnology Working Party (BWP): Note for Guidance on allergen products; CPMP/BWP/243/96. 1996.
17. Calderon MA, Alves B, Jacobson M, Hurwitz B, Sheikh A, Durham S,. Allergen injection immunotherapy for seasonal allergic rhinitis. Cochrane Database Syst Rev 2007; Jan 24;(1):CD001936.
18. Abramson MJ, Puy RM, Weiner JM,. Allergen immunotherapy for asthma. Cochrane Database Syst Rev 2003; (4): CD001186.
19. Canonica GW, Baena-Cagnani CE, Bousquet J, Bousquet PJ, Lockey RF, Malling HJ, etal. Recommendations for standardization of clinical trials with Allergen Specific Immunotherapy for respiratory allergy. A statement of a World Allergy Organization (WAO) taskforce. Allergy 2007; 62: 317 -324.
20. Nordic Council on Medicines. Registration of allergen preparations: Nordic guideline. NLN Publication 1989; 23: 1 -34.
21. Spangfort MD, Larsen JN,. Standardization of allergen-specific immunotherapy vaccines. Immunol Allergy Clin North Am 2006; 26: 191 -206, v-vi.
22. U.S.Department of Health and Human Services, Food and Drug Administration. Guidance for industry, allergic rhinitis: clinical development programs for drug products, draft guidance (2781 draft/06/14/00). 2000.
23. Bousquet J, Muller UR, Dreborg S, Jarisch R, Malling HJ, Mosbech H, etal. Immunotherapy with Hymenoptera venoms. Position paper of the Working Group on Immunotherapy of the European Academy of Allergy and Clinical Immunology. Allergy 1987; 42: 401 -413.
24. WHO/IUIS Working Group. The current status of allergen immunotherapy (hyposensitisation). Report of a WHO/IUIS working group. Allergy 1989; 44: 369 -379.
25. World Health Organisation/International Union of Immunological Societies Working Group. Current status of allergen immunotherapy. Shortened version of a World Health Organisation/International Union of Immunological Societies Working Group Report. Lancet 1989; 1: 259 -261.
26. International Asthma Management Project. International Consensus Report on Diagnosis and Management of Asthma. Allergy 1992; 47: 1 -61.
27. Global initiative for asthma (GINA): global strategy for asthma management and prevention (update 2008). 2009.
28. International Rhinitis Management Working Group. International Consensus Report on the diagnosis and management of rhinitis. Allergy 1994; 49: 1 -34.
29. Frew AJ,. Injection immunotherapy. British Society for Allergy and Clinical Immunology Working Party. BMJ 1993; 307: 919 -923.
30. Joint Task Force on Practice Parameters, representing the American Academy of Allergy, Asthma and Immunology, the American College of Allergy, Asthma and Immunology, and the Joint Council of Allergy, Asthma and Immunology. Practice parameters for allergen immunotherapy. J Allergy Clin Immunol 1996; 98: 1001 -1011.
31. Committee for Medicinal Products for Human Use (CHMP) and Efficacy Working Party (EWP): Guideline on the clinical development of products for specific immunotherapy for the treatment of allergic diseases; EMEA/CHMP/EWP/18504/2006. 2008.
32. Committee for Proprietary Medicinal Products (CPMP): Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (ICH Topic E 2 A); CPMP/ICH/377/95. 1995.
33. Committee for Proprietary Medicinal Products (CPMP): Note for Guidance on Good Clinical Practice (ICH Topic E6); CPMP/ICH/135/95. 2002.
34. Bundesgesetzblatt, Teil 1, Nr. 54. Arzneimittelgesetz AMG 14. Gesetz zur Änderung des Arzneimittelgesetzes. 2005.
35. Verordnung über die Ausdehnung der Vorschriften über die Zulassung der Arzneimittel auf Therapieallergene, die für einzelne Personen auf Grund einer Rezeptur hergestellt werden, sowie über Verfahrensregelung der staatlichen Chargenprüfung (Therapieallergene-Verordnung). Bundesgesetzblatt 2008; Teil I, Nr. 51: 2177-8.
36. UK Committee on Safety of Medicines. CSM update: desensitising vaccines. BMJ 1986; 293: 948.
37. Okuda M,. Grading the severity of allergic rhinitis for treatment strategy and drug study purposes. Curr Allergy Asthma Rep 2001; 1: 235 -241.
38. Bousquet PJ, Demoly P, Passalacqua G, Canonica GW, Bousquet J,. Immunotherapy: clinical trials -optimal trial and clinical outcomes. Curr Opin Allergy Clin Immunol 2007; 7: 561 -566.