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The discovery and development of belimumab: the anti-BLyS–lupus connection

Nature Biotechnology volume 30, pages 69–77 (2012)Cite this article

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Abstract

For the first time in more than 50 years, the US Food and Drug Administration has approved a drug specifically for the treatment of systemic lupus erythematosus (SLE). This drug, belimumab (Benlysta), is a human monoclonal antibody that neutralizes the B-cell survival factor, B-lymphocyte stimulator (BLyS). The approval of belimumab combined a pioneering approach to genomics-based gene discovery, an astute appreciation of translational medicine, a disciplined clinical strategy, a willingness to take calculated risks, a devoted cadre of patients and physicians and a healthy dose of serendipity. Collectively, these efforts have provided a model for the development of a new generation of drugs to treat the broad manifestations of SLE. However, as a substantial percentage of SLE patients do not respond to belimumab, further research is needed to better characterize the pathogenetic mechanisms of SLE, identify additional therapeutic targets, and develop effective and nontoxic novel agents against these targets.

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Figure 1: Important milestones in belimumab (Benlysta) achieving FDA approval in SLE.
Figure 2
Figure 3: The effect of belimumab on the binding of BLyS to its receptors.

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Acknowledgements

The authors thank T.-S. Migone and W. Freimuth of HGS for helpful discussions and assistance with the time line. The work was supported in part by NIH grant R01 AR050193 to W.S.

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  1. Division of Rheumatology, University of Southern California Keck School of Medicine, Los Angeles, California, USA

    William Stohl

  2. Zyngenia, Inc., Gaithersburg, Maryland, USA

    David M Hilbert

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Correspondence to William Stohl.

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W.S. received clinical trials support from Human Genome Sciences. D.M.H. is a former employee of Human Genome Sciences and a current employee of Zyngenia.

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Stohl, W., Hilbert, D. The discovery and development of belimumab: the anti-BLyS–lupus connection. Nat Biotechnol 30, 69–77 (2012). https://doi.org/10.1038/nbt.2076

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