Five years after approval by the FDA and EMA, IV Benlysta remains the only drug licensed for the treatment of SLE in almost 60 years, highlighting the difficulty in successfully bringing to market agents to treat this multifactorial disease. Despite the high level of unmet need in SLE, IV Benlysta has seen slow uptake, especially in some European markets, owing to a combination of factors including high price, modest efficacy, low response rate, and slow onset of action. Thus, the level of unmet need in SLE remains high, and significant clinical and commercial opportunities persist for therapies that can provide superior efficacy in reducing disease activity, help to decrease use of corticosteroids, and improve quality of life of patients with SLE.


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