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07 June 2024
Allergy, Food Allergy
CARE, - Medicines

At the end of May, EFA submitted our allergy community response to a key consultation for the allergy patient community: a Guideline on the development of allergen products for immunotherapy and allergy diagnosis in cases where the available population for clinical trials is limited. EFA allergy community gathered in a workshop to respond to this consultation organised by the European Medicines Agency (EMA). 

What is in the new guideline for allergy patients?

Allergy is an immensely complex disease, with many different sub-types and numerous potential allergy sources. In certain cases of less common allergies, it is not possible to gather a sufficient number of patients in the clinical process for the development of products for allergen immunotherapy (AIT) and diagnosis. This results often with the situation in which treatments or diagnosis for these allergy types might be severely limited, or even non-existent, creating a significant unmet need for patients. With this Guideline, EMA seeks to give clarity to developers and enable research and hopefully products in the allergy field. 

The draft Guideline covers diagnostic allergens for in vivo tests (prick test, provocation test, epicutaneous patch test), as well as inhalant allergens and food allergens used for AIT. It is relevant to several types of allergies, including allergy to pollen, dust, animal dander, mould, food, and chemicals. 

A patient-centred approach to fill in the gaps in allergy immunotherapy and diagnosis 

EFA allergy community welcomed the draft Guideline and praised EMA for its commitment to address the disease burden of allergy and unmet needs, leaving no one behind.

We fully supported the advancement of the work on treatment and diagnosis for allergy: on the one hand, AIT can pave the way towards a personalised approach based on more tailored treatments; on the other hand, any advancement on a notoriously underdiagnosed condition, such as allergy, is essential for patients. 

EFA Community highlighted the following general recommendations: 

Better information on clinical trials for patients: Guidelines like this can help improve patient access to clinical trials, often hampered by lack of information on how patients can attend, the benefits and risks, geographic distance etc. It is key to focus on informing patients in a clear and timely manner, and even more important in the case of uncommon allergies, where the patient population is scarce.

A balance between patient safety and access to medical products: With its guideline, EMA should strike the right balance between patient safety and access to medical products, making sure that the introduction of specific criteria does not lead to downsizing the products available in the market.

Younger patients in clinical trials: EFA supports the inclusion of paediatric population in clinical studies and trials, especially when linked to a disease for which there is not cure e.g. food allergy.

Existing data should be taken into account: The study of low-prevalence allergy could benefit from including the collection and analysis of Real-World Data (e.g. related to Quality of Life) or even via the development and analysis of specific patient-reported outcomes.

The allergy patient community also brought up specific recommendations regarding certain aspects of the Guideline: 

Food allergy should be considered: Whereas the draft Guideline defines treatment goals for AIT development only for allergic rhinitis/rhinoconjunctivitis, EFA insists adding treatment goals for food allergy too, as another disease where AIT should be an option. There are many uncommon allergies to food, including to product categories of known food allergens e.g. macadamia nuts;

Treatments must be suitable for different ages: Patient selection criteria need to be enriched, taking into account the route of administration and the age of the individuals tested. We call EMA to give proper consideration of existing conditions e.g. when using patches with adhesive to patients with skin disease such as atopic eczema, or when using injections to children.

Allergy testing on rhinitis patients: When selecting rhinitis patients, EFA stresses that in specific cases patients may test negative in skin prick test and allergen-specific IgE test (which are the criteria set by the Guideline); but test positive only in a nasal provocation test. EFA asks that a positive nasal provocation test should be sufficient to be eligible for clinical trial on an AIT product.

Include child patients in safe clinical trials: Regarding special populations such as children, EFA understands the legal and ethical reasons of prioritising adults in clinical trials. Yet we stress that extrapolation is not a correct method as the immune system of children is different from adults. Especially in food allergy, the focus group should be the children, given that most allergies develop during childhood. Besides, existing evidence shows that the ideal age to determine the tolerance of the immunity system to a specific food allergy is early childhood, which explains why studies on children prove more effective than those on adults. By any means, clinical trials with children need to be conducted based on the highest ethical and safety standards, and ensure that children are well-informed, asked for their consent, and respected.

You can find EFA’s full response to the consultation here

EFA is grateful to its members in the Allergy & Asthma and Food Allergy Working Groups, whose insightful input was critical in building a comprehensive response to this key consultation.