Regulatory challenges for new drugs to treat obesity and comorbid metabolic disorders
Open accessAbstract
Obesity is a major cause of morbidity and mortality through cardio‐ and cerebrovascular diseases and cancer. The metabolic consequences of obesity include dyslipidaemia, hypertension, proinflammatory atherogenesis, pre‐diabetes and Type 2 diabetes. For a significant proportion of patients, pharmacotherapy to tackle obesity is required as adjunctive support to diet, exercise and lifestyle modification. To this end, the pharmaceutical industry is pursuing many novel drug targets. Although this view is probably not justified, the recent tribulations of rimonabant have created a perception that the regulatory bar for the approval of antiobesity drugs has been raised. Although >5% of placebo‐subtracted weight loss maintained over 1 year is the primary efficacy end‐point, it is improvements in cardiovascular risk factors that the Food and Drug Administration (FDA) and European Medicines Agency (EMEA) require to grant approval. Safety aspects are also critical in this indication. Many companies are now switching development of their antiobesity drug candidates into other metabolic disorders. Type 2 diabetes is accepted by the industry and FDA, but not EMEA, as the most appropriate alternative. On the other hand, improvements in plasma lipids produced by antiobesity drugs are moderate compared with established therapies, suggesting dyslipidaemia is not a viable development option. Metabolic Syndrome is not accepted by FDA or EMEA as a discrete disease and the agencies will not licence antiobesity drugs for its treatment. The regulatory environment for antiobesity drugs and the spectrum of indications for which they can be approved could change dramatically if positive data for sibutramine emerge from the SCOUT outcome trial.
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Disparities exist in the regulatory approval and availability of OMMs across different countries.
“Disparities exist in the regulatory approval and availability of OMMs across different countries64–66.”
From A systematic review and meta-analysis of the efficacy and safety of pharmacological treatments for obesity in adults (2025) · cites this paper as [64]
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Pharmacotherapy of obesity: an update on the available medications and drugs under investigation
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- Authors
- Heal, D. J., Gosden, J., & Smith, S. L.
- Affiliations
- RenaSci (United Kingdom) (GB)
- Corresponding author
- Heal, David J.
- Venue
- British Journal of Clinical Pharmacology
- Publisher
- Wiley
- Published
- 2009-11-27
- Volume
- 68
- Issue
- 6
- Pages
- 861-874
- ISSN
- 0306-5251 (ISSN-L)
- 1365-2125
- PMC
- PMC2810797
- OpenAlex
- W2013623792
- Cited by
- 86
- References
- 11
- Citations by year
- 2026: 2 · 2025: 4 · 2023: 2 · 2022: 1 · 2021: 3 · 2020: 2 · 2019: 3 · 2018: 1 · 2017: 6 · 2016: 8 · 2015: 3 · 2014: 10 · 2013: 10 · 2012: 9
- FWCI
- 7.45
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- British Journal of Clinical Pharmacology (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
- Keywords
- anti-obesity drugs, drug regulation, regulatory approval, rimonabant, type 2 diabetes, metabolic syndrome, dyslipidemia, cardiovascular risk factors, sibutramine, drug safety
- MeSH terms
- Adult, Child, Diabetes Mellitus, Type 2, Female, Humans, Hypoglycemic Agents, Male, Obesity, Risk Factors, Drug Design, Drugs, Investigational, Drug Approval, Anti-Obesity Agents, Metabolic Syndrome, Young Adult
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