- 16
Guideline on allergen products development for
immunotherapy and allergy diagnosis in moderate to lowsized study populations
17
Table of contents
18
Executive summary ..................................................................................... 3
19
1.
- Specific effects ................................................................................................. 17
14
15
Guideline on allergen products development for immunotherapy and allergy diagnosis
in moderate to low-sized study populations
EMA/CHMP/72790/2024
Page 2/18
53
12.
- Management for allergies may involve avoidance of the allergen, medications to relieve
66
symptoms, or allergen immunotherapy (AIT) to desensitize the immune system to the allergen.
- 71
Recommendations are made on the clinical development, potential study designs and safety
72
considerations for allergen products within the scope of the guideline.
- Guideline on allergen products development for immunotherapy and allergy diagnosis
in moderate to low-sized study populations
EMA/CHMP/72790/2024
Page 3/18
88
While allergen specific immunotherapy is the only known disease modifying therapy for type I allergies,
89
there is no such treatment available for type IV allergies.
- 93
Several guidelines applicable for allergen products are available (see section 3) and provide advice on
94
quality and clinical development according to the current knowledge.
- Guideline on allergen products development for immunotherapy and allergy diagnosis
in moderate to low-sized study populations
EMA/CHMP/72790/2024
Page 4/18
127
However, this guideline does not cover the indication of atopic dermatitis or asthma as these
128
conditions will require separate clinical trials (see Section 6).
- 129
In addition, the guideline does not cover medicinal allergen products manufactured using recombinant
130
DNA technology, synthetic peptides, DNA or RNA constructs and/or cell preparations as they differ
131
substantially to the allergen products as discussed above.
- 1
156
?
Guideline on the clinical development of products for specific immunotherapy for the treatment
157
158
of allergic diseases - CHMP/EWP/18504/2006
?
159
160
161
Guideline on Allergen Products: Production and Quality Issues EMEA/CHMP/BWP/304831/2007
?
Guideline on process validation for finished products - information and data to be provided in
regulatory submissions - EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1, Corr.1
Guideline on allergen products development for immunotherapy and allergy diagnosis
in moderate to low-sized study populations
EMA/CHMP/72790/2024
Page 5/18
162
?
Recommendations on common regulatory approaches for allergen products - CMDh/399/2019
163
4.
- In any
199
case, a reduced validation should include all relevant manufacturing process steps that are considered
Guideline on allergen products development for immunotherapy and allergy diagnosis
in moderate to low-sized study populations
EMA/CHMP/72790/2024
Page 6/18
200
product specific.
- 290
Diagnostic allergen products (Type I allergy)
291
A possible target indication is diagnosis of type I hypersensitivity (immediate-type allergy) by prick,
292
intracutaneous or provocation testing.
- 298
Guideline on allergen products development for immunotherapy and allergy diagnosis
in moderate to low-sized study populations
EMA/CHMP/72790/2024
Page 9/18
305
306
7.1.
- Guideline on allergen products development for immunotherapy and allergy diagnosis
in moderate to low-sized study populations
EMA/CHMP/72790/2024
Page 11/18
377
8.
- Clinical development of products for AIT: Study design,
efficacy and safety
378
In general, the clinical development should be performed according to current guidelines.
- In such single trial, the suitability as a test allergen as well as the
376
Guideline on allergen products development for immunotherapy and allergy diagnosis
in moderate to low-sized study populations
EMA/CHMP/72790/2024
Page 12/18
415
dose finding for the therapeutic allergen could be investigated.
- Guideline on allergen products development for immunotherapy and allergy diagnosis
in moderate to low-sized study populations
EMA/CHMP/72790/2024
Page 13/18
454
455
8.2.1.
- 493
Guideline on allergen products development for immunotherapy and allergy diagnosis
in moderate to low-sized study populations
EMA/CHMP/72790/2024
Page 15/18
527
In general, sensitivity and specificity of the product should be determined.
- 540
Guideline on allergen products development for immunotherapy and allergy diagnosis
in moderate to low-sized study populations
EMA/CHMP/72790/2024
Page 16/18
561
10.2.
- Guideline on allergen products development for immunotherapy and allergy diagnosis
in moderate to low-sized study populations
EMA/CHMP/72790/2024
Page 17/18
595
4.
- Allergol Immunopathol, 1989;
602
17(2):53-65
603
Guideline on allergen products development for immunotherapy and allergy diagnosis
in moderate to low-sized study populations
EMA/CHMP/72790/2024
Page 18/18
