Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The increasing burden of Allergic Asthma – Regulatory framework of common treatment strategies and innovative therapies

Dr. Helen Meyer-Martin (Abschlußjahr: 2017)

Summary
The actual master thesis elucidates the regulatory framework of common treatment strategies and innovative therapies for allergic asthma. Although allergic asthma has already reached epidemic proportions worldwide the disease still shows an increasing tendency. While 300 million people are affected currently, it is estimated that 400 million patients will be impacted in 2025.
Due to the complex heterogeneity of asthma an accurate evaluation of a patient´s phenotype is necessary to ensure optimal treatment approaches. The Global Initiative for Asthma offers guidance for evaluation of the individual phenotype and disease management.
Many different options are available for the treatment of allergic asthma, among them quick-relief rescue medications as well as long-term control medications. Basic treatments comprise anti-inflammatory agents, such as corticosteroids, bronchodilators, antileukotrienes or antibodies. Fixed dose combinations with two active substances are commonly used for asthma patients. All treatment approaches aim to reduce the inflammation in the airways and focus on reduction of symptoms. The specific immunotherapy even provides a chance on stable improvement and cure.
Besides common standards on development, manufacture and marketing authorization asthma medications have to conform special considerations depending on the type of medication. In this context, specific guidance is available on clinical investigation of medicinal products for the treatment of asthma, as well as inhalers, specific immunotherapy and antibodies.
As a particularly challenge prospective legislation has to meet the requirements of the growing need for personalized treatment approaches not only for diseases like allergic asthma.
Pages: 63