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R&D Trends: Systemic Lupus Erythematosus - Benlysta's FDA approval provides hope for disease treatment, future trial design, and other pipeline candidates
Datamonitor, May 2011, Pages: 62
There remains considerable debate over the optimum efficacy measure and clinical trial design in SLE. While the SLE Responder Index has proved successful in demonstrating the efficacy of Benlysta (belimumab; Human Genome Sciences/GlaxoSmithKline) such that many other trials are now following suit, it is unclear if this will spur other successes.
Features and benefits
- Benchmark novel and existing therapies using the ideal target product profiles identified by Datamonitor and access leading rheumatologists’ opinion
- Support R&D decision making by evaluating lupus clinical trial designs that have set a precedent, as well as analysis of discontinued projects
Highlights
- Datamonitor identified 32 drug candidates in development for systemic lupus erythematosus (SLE), with four products in Phase III. Recent negative outcomes of major clinical trials threaten to move industry away from drug development in SLE, but Benlysta’s recent US approval may ignite further commercial interest in this disease.
- Two new B-lymphocyte stimulator (BLyS) candidates have emerged within the late-stage SLE pipeline. Eli Lilly’s LY2127399 and Anthera Pharmaceuticals’ A-623 are both being investigated based on the novel SLE Responder Index. While this approach was successful for Benlysta, it remains to be seen if this can be emulated by other candidates.
- The FDA published its formal guidance for industry for developing a medical product for SLE in June 2010, pointing to the use of disease activity indices in clinical trials. However, many specialists believe that the answer is to move away from these kinds of instruments and to check objective measures, such as biomarkers.
Your key questions answered
- What lessons can be learned from past clinical trials in SLE and how can these be applied to novel pipeline candidates?
- How does the recent approval of Benlysta impact the future of drug development for SLE?
- What are the most promising trends seen in early stages of the SLE pipeline?
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