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The pharmaceutical market for obesity therapies

Nature Reviews Drug Discovery volume 11, pages 669–670 (2012)Cite this article

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Experts agree that a sustained reduction of at least 5% in body weight can reduce the risk of obesity-related cardiovascular disease and diabetes. A 5% placebo-adjusted mean weight loss is the minimum threshold for approval cited in guidelines issued by regulatory authorities, although clinicians and patients generally have higher expectations and desire significantly greater efficacy of at least 10% weight loss. The modest efficacy offered by currently available agents, a history of poor tolerability and safety setbacks, a paucity of novel therapies, and lack of reimbursement have substantially constrained the pharmaceutical market for obesity therapies.

Long-term safety concerns have been the predominant issue affecting physician prescribing habits and the actions of regulatory agencies. Of the drugs that have been marketed over the past 40 years (Supplementary information S1 (table)), five were subsequently withdrawn owing to safety concerns. The most notable obesity drug withdrawals were those of fenfluramine (Pondimin; Wyeth) and dexfenfluramine (Redux; Wyeth) in 1997. These two agents were prescribed off-label with phentermine as the 'fen-phen' combination and experienced strong sales owing to the efficacy of the combination; however, both compounds were withdrawn a year after launch owing to an increased risk for cardiac valvulopathy. More recently withdrawn drugs such as sibutramine (Abbott's Meridia/Reductil; withdrawn in 2010 because of cardiovascular risk), benfluorex (Servier's Mediator; withdrawn in 2009 because of valvulopathy risk) and rimonabant (Sanofi-Aventis's Acomplia; withdrawn in 2008 because of risk for depression and suicidal ideation) have further added to the heightened caution shown by regulatory agencies.

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Figure 1: Major-market sales of obesity therapies 2011–2021.

References

  1. Prospective Studies Collaboration. Body-mass index and cause-specific mortality in 900,000 adults: collaborative analyses of 57 prospective studies. Lancet 373, 1083–1096 (2009).

  2. Cawley, J. & Meyerhoefer, C. The medical care costs of obesity: an instrumental variables approach. J. Health Econom. 31, 219–230 (2012).

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Authors and Affiliations

  1. Kate Sullivan, B.Sc., and Gideon Heap, M.Sc., are research analysts at Decision Resources.,

    Kate Sullivan & Gideon Heap

  2. Donny Wong, M.M.Sc., Ph.D., is Director of Metabolic Disorders at Decision Resources, 10–15 Queen Street, Aldermary House, London EC4N 1TX, United Kingdom.,

    Donny Wong

Authors
  1. Donny Wong
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  2. Kate Sullivan
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  3. Gideon Heap
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Correspondence to Donny Wong.

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The authors declare no competing financial interests.

Supplementary information

Supplementary information Table 1

FDA- and EMA-Approved Obesity Drugs, 1957-2012 (PDF 163 kb)

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Wong, D., Sullivan, K. & Heap, G. The pharmaceutical market for obesity therapies. Nat Rev Drug Discov 11, 669–670 (2012). https://doi.org/10.1038/nrd3830

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