Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The obese patient - regulatory framework and challenges for the development, approval and prescription of medicinal products used in overweight subjects with a focus on the European Union ***

Dr. Alexandra Baumann (Abschlußjahr: 2019)

Summary
Language: English
Overweight and obesity are an increasing trend worldwide. In 2017, over 50 % of Europeans have been overweight and nearly 16 % of them have been obese. Overweight and especially obesity are the cause of a variety of health issues and co-morbidities including cardiovascular disease, type 2 diabetes mellitus, and stroke. Excessive overweight and the accompanying health risks do not only pose a challenge for the individual but also cause a huge burden for the economy. In the majority of cases, overweight is caused by an imbalance of calorie intake and consumption. Despite a variety of weight loss programs and diets, weight loss and especially long-term weight maintenance often fails. The best success is made by a multimodal weight management program that includes a proper diet, increased physical activity and behavioral modification. In addition, weight loss and weight maintenance can be further supported by pharmaceutical treatment options. This Master Thesis provides an overview on the currently marketed weight management drugs in Europe, regulatory requirements for the clinical development and approval of such products based on the available guidance and reasons for the low number of currently approved drugs. Based on CHMP assessment reports of approved, rejected and suspended drugs the biggest challenges for pharmaceutical companies and health authorities are identified and recommendations for a successful development, approval and maintenance of pharmaceutical treatment options are presented.
As any other patient, overweight and obese patients are frequently treated for any other acquired diseases. However, the pharmacokinetics of these patients may differ significantly due to altered absorption, distribution, drug metabolism and excretion. A total of 412 product information of drugs authorized between 2008 and 2018 via the centralized procedure have been screened for information regarding dosing and treatment of overweight patients. While the product information of drugs nowadays usually describes the requirements for dosing adjustments in children and elderly patients, dedicated dosing recommendations for overweight and obese patients are still rare. This may pose a risk for over- or underdosing possibly resulting in treatment failure or increased side effects. In 2018, a reflection paper on the requirements of dedicated pharmacokinetic investigations in overweight subjects has been released by the EMA. The potential of this guidance to improve the treatment of overweight patients is critically discussed in this thesis.
Pages: 84, Annexes 2: pages: 16