Draft guideline on allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populations
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Guideline on allergen products development for
immunotherapy and allergy diagnosis in moderate to lowsized study populations17
Table of contents
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Executive summary ..................................................................................... 3
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1.
- Specific effects ................................................................................................. 17
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12.
- Management for allergies may involve avoidance of the allergen, medications to relieve
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symptoms, or allergen immunotherapy (AIT) to desensitize the immune system to the allergen.
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Recommendations are made on the clinical development, potential study designs and safety
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considerations for allergen products within the scope of the guideline.
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While allergen specific immunotherapy is the only known disease modifying therapy for type I allergies,
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there is no such treatment available for type IV allergies.
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Several guidelines applicable for allergen products are available (see section 3) and provide advice on
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quality and clinical development according to the current knowledge.
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However, this guideline does not cover the indication of atopic dermatitis or asthma as these
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conditions will require separate clinical trials (see Section 6).
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In addition, the guideline does not cover medicinal allergen products manufactured using recombinant
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DNA technology, synthetic peptides, DNA or RNA constructs and/or cell preparations as they differ
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substantially to the allergen products as discussed above.
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Guideline on the clinical development of products for specific immunotherapy for the treatment
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158of allergic diseases - CHMP/EWP/18504/2006
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161Guideline on Allergen Products: Production and Quality Issues EMEA/CHMP/BWP/304831/2007
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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.1Guideline on allergen products development for immunotherapy and allergy diagnosis
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Recommendations on common regulatory approaches for allergen products - CMDh/399/2019
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4.
- In any
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case, a reduced validation should include all relevant manufacturing process steps that are considered
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product specific.
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Diagnostic allergen products (Type I allergy)
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A possible target indication is diagnosis of type I hypersensitivity (immediate-type allergy) by prick,
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intracutaneous or provocation testing.
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3067.1.
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8.
- Clinical development of products for AIT: Study design,
efficacy and safety378
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
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dose finding for the therapeutic allergen could be investigated.
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4558.2.1.
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In general, sensitivity and specificity of the product should be determined.
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10.2.
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4.
- Allergol Immunopathol, 1989;
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