Systemic Lupus Erythematosus | Unmet Need | Lupus Nephritis | US/EU | 2023

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 gain approval for the treatment of active LN. In January 2021, Aurinia’s Lupkynis was granted FDA approval for the same patient population. Despite these approvals, unmet need remains high in this indication, leaving significant commercial opportunity for novel LN therapies.

Questions answered

• 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?

Product description

Unmet need supports clinical development decisions by identifying key attributes and assessing areas of unmet need for a specific disease or subpopulation. Based on surveys with U.S. and European physicians, this report provides insight into key treatment drivers and goals, the performance of current therapies, and the remaining commercial opportunities. One market scenario is profiled in detail by Clarivate experts, and additional customized market scenarios can be evaluated with the corresponding TPP simulator.

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

Primary research: Survey of 31 U.S. rheumatologists, 30 U.S. nephrologists, and 30 European rheumatologists fielded in February 2023.

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

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