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Allergic Reactions

Allergic Reactions

Allergic Reactions: Anaphylaxis

Allergic Reactions: Anaphylaxis

Anaphylaxis is a severe, life-threatening hypersensitivity reaction mediated by Immunoglobulin E (IgE) antibodies. When IgE binds to allergens, it triggers the release of mediators– histamine, leukotrienes, and prostaglandins from mast cells and basophils. These mediators cause vasodilation, edema, and inflammation, leading to various symptoms.The primary allergens causing anaphylaxis include food items (e.g., peanuts, shellfish), drugs (e.g., penicillin, asparaginase, corticotropin, heparin),...

Allergic Drug Reactions

Allergic Drug Reactions

Allergic reactions related to drugs are hypersensitivity responses driven by the immune system and bear no connection to the drug's therapeutic action. While drugs in isolation do not trigger an immune response, they can interact with endogenous proteins to form antigens. These antigens stimulate lymphocytes to produce antibodies. IgE-type antibodies attach themselves to mast cells. Upon subsequent exposure to the same stimulus, the antigen-antibody interaction is initiated, unleashing numerous...

Drug Toxicity: Allergic Reactions

Drug Toxicity: Allergic Reactions

Drug-related allergies are immune-mediated responses triggered by the administration of pharmacological agents. These hypersensitivity reactions are classified based on the immune mechanisms involved. The four primary types—Type I, II, III, and IV—are mediated by different immunological pathways and exhibit distinct clinical manifestations.Type I Hypersensitivity/ IgE-Mediated Reactions: Immunoglobulin E (IgE) immediately mediates Type I hypersensitivity reactions. Upon initial exposure to a...

Hypersensitivities

Hypersensitivities

Hypersensitivity, also known as a hypersensitivity reaction or allergic reaction, is a condition where the body's immune system reacts abnormally to a foreign substance. Such substances, that cause hypersensitivity are referred to as an allergen, could be something typically harmless to most people, like pollen or certain foods.
Types of Hypersensitivities
Hypersensitivity reactions are categorized into four types: Type 1, Type 2, Type 3, and Type 4. Each type has a distinct mechanism...

Antiasthma Drugs: Mast Cell Stabilizers and Anti-IgE Drugs

Antiasthma Drugs: Mast Cell Stabilizers and Anti-IgE Drugs

Asthma is a chronic respiratory condition for which new therapeutic avenues, including anti-inflammatory drugs like mast cell stabilizers and anti-IgE treatments, continue to be developed.
Mast cell stabilizers, such as cromolyn (also known as sodium cromoglycate) and nedocromil (Tilade), are effective drugs in asthma management. These stabilizers hinder histamine release by skillfully obstructing the activation of mast cells and other cellular entities. Notably, they navigate this task without...

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Updated: Jun 4, 2026

Symptom Assessment of Patients with Allergic Rhinitis Using an Allergen Exposure Chamber

Symptom Assessment of Patients with Allergic Rhinitis Using an Allergen Exposure Chamber

Published on: March 3, 2023

Regulatory environment for allergen-specific immunotherapy.

S Kaul¹, S May, D Lüttkopf

¹Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Division of Allergology, Langen, Germany.

|February 4, 2011

Summary

Specific immunotherapy (SIT) products are regulated medicinal products in Europe. Obtaining marketing authorization requires proving quality, safety, and efficacy through rigorous trials and regulatory procedures.

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Area of Science:

Regulatory Affairs
Immunotherapy
Pharmaceutical Sciences

Background:

Specific immunotherapy (SIT) products are classified as medicinal products under European Regulations.
Marketing authorization (MA) in the European Community necessitates comprehensive proof of quality, safety, and efficacy.
The development phase offers opportunities for scientific advice from regulatory authorities like the European Medicines Agency (EMA).

Purpose of the Study:

To outline the regulatory requirements for obtaining marketing authorization for specific immunotherapy (SIT) products in the European Community.
To describe the available regulatory procedures for marketability across European member states.
To highlight the unique regulatory status of Named Patient Products for SIT.

Main Methods:

Review of European Regulations pertaining to medicinal products and specific immunotherapy.
Analysis of marketing authorization procedures, including national, Mutual Recognition, Decentralized, and Centralized Procedures (CP).
Examination of requirements for scientific advice and Paediatric Investigation Plans.

Main Results:

Marketing authorization requires demonstrating quality, safety, and efficacy through nonclinical and clinical trials.
Various regulatory pathways exist, with the Centralized Procedure (CP) being mandatory for certain products like recombinant allergens.
Named Patient Products for SIT represent a special category, manufactured individually and marketed without a MA.

Conclusions:

Navigating the European regulatory landscape for SIT products is complex, requiring adherence to specific guidelines.
The Centralized Procedure (CP) is crucial for advanced therapies, while Named Patient Products operate under a distinct framework.
Understanding these regulatory nuances is essential for successful product development and market access for SIT therapies.