Systemic Lupus Erythematosus | Unmet Need | Lupus Nephritis | US/EU | 2021

Renal inflammation associated with SLE, also known as LN, is among the most serious manifestations of the disease. Until recently, no therapy was specifically approved for LN. Most treatments are old, genericized, and off-label, owing to the difficulty of developing novel treatments for this complex disease. In December 2020, the FDA granted a label extension for GlaxoSmithKline’s Benlysta, making it the first drug to win approval for the treatment of active LN. In January 2021, Aurinia’s Lupkynis was granted FDA approval for the same patient population. Despite these recent approvals, unmet need remains high in this indication, leaving significant commercial opportunity for novel LN therapies.


  • What are the treatment drivers and goals for active LN?
  • What clinical and nonclinical drug attributes are key influences, which have limited impact, and which are hidden opportunities in the treatment of active LN?
  • How do rheumatologists and nephrologists rate current therapies in terms of their performance on key treatment drivers and goals for active LN?
  • What are the prevailing areas of unmet need and opportunity in the treatment of active LN?
  • What trade-offs across key drug attributes and price are acceptable to physicians for a hypothetical new drug for LN?


Provides quantitative insight into U.S. and European physician perceptions of key treatment drivers and goals and the current level of unmet need for a specific disease. Commercial opportunities are analyzed, and the extent to which emerging therapies may capitalize on these opportunities is evaluated.

Markets covered: United States, United Kingdom, France, Germany

Primary research: Survey of 30 U.S. rheumatologists, 30 U.S. nephrologists, and 30 European rheumatologists fielded in February 2021

Key companies: GlaxoSmithKline, Aurinia Pharmaceuticals, Biogen / Roche / Genentech

Key drugs: Benlysta, Rituxan / MabThera, mycophenolate mofetil, cyclophosphamide (IV), hydroxychloroquine, azathioprine, tacrolimus

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