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The European Medicines Agency (EMA) launched a public consultation on the basis of a concept paper for a ‘Guideline for allergen products development in moderate to low-sized study populations’.

The proposal tackles the cases where the evaluation of an allergen product is inadequate due to the lack of sufficient number of patients for the clinical trials. This is true for various types of allergies (low prevalence), which creates an unmet medical need for effective diagnosis and treatment.

So far, one of the major barriers has been the existence of several allergies in individual patients, which makes the identification of patients with just one allergy challenging.

The future guideline aims to address this and other problems, covering general aspects of allergen product development such as patient selection, efficacy assessment, therapeutic studies design, safety and quality considerations.

EFA welcomes the initiative, as it addresses an unmet medical need in disease areas of limited or no targeted and effective treatment options, which are easily overlooked or considered as covered by existing guidelines and treatments.

EFA main points to EMA public consultation on allergen product development in low-sized populations

EFA participated in the public consultation by further pointing the following aspects:

  • EMA should put forward a list with all the types of allergy that will fall under the proposed guideline, as a way to ensure regulatory clarity and informed decision-making by healthcare professionals and patients.
  • In the discussion about allergic rhinitis/rhino conjunctivitis, EFA suggests adding an element on the quality of life of patients.
  • Given the limits imposed by the difficulty to find patients with just one allergy, EFA calls for the development of clinical trial samples that are closer to the real allergy patient population, that is, people living with a spectrum of atopic disease and (allergic) asthma, beyond just one low prevalence allergy. At the same time, low prevalence diseases could be better studied through techniques such as the collection and analysis of Real World Data or even via the development and analysis of specific patient-reported outcomes that could then lead to a more standard clinical trial approach.
  • Although EFA acknowledges that allergies are multi-systemic diseases that typically affect multiple organs, we insist that the general lines of effective diagnosis and treatment of allergy in clinical care should only be set by medical doctors with specialised training in allergology.

The full EFA response to the EMA consultation on allergen product development in low-sized populations is available here.

We thank all our Members from EFA Asthma and Allergy, and EFA Atopic Eczema Working Groups for their contributions in putting this response together.

Tags: Category: News
Country: EU
Disease area: Allergy,Food allergy
Theme: Healthcare