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Historically, developers of systemic lupus erythematosus (SLE) drugs faced formidable challenges: drug development and regulatory hurdles, a small and heterogeneous population, and a multiplicity of manifestations. Recent positive clinical trial results and the regulatory approval of belimumab (GlaxoSmithKline’s Benlysta)—the first new agent in 50 years—have lowered some development hurdles, and a growing list of emerging agents has ushered in a new era of SLE drug development. We forecast that sales of SLE therapies will increase approximately threefold during our 2013-2023 forecast period, driven largely by the entry and uptake of premium-priced biologics.

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