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Follow on Google News | Just Released: "R&D Trends: Systemic Lupus Erythematosus"New Pharmaceuticals market report from Datamonitor: "R&D Trends: Systemic Lupus Erythematosus - Benlysta's FDA approval provides hope for disease treatment, future trial design, and other pipeline candidates"
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) 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 ------------------------------------------------------------ Full Report Details at - http://www.fastmr.com/ ------------------------------------------------------------ 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? Report Table of Contents: Executive Summary Strategic scoping and focus Datamonitor key findings Related reports OVERVIEW Catalyst Summary CLINICAL PIPELINE OVERVIEW Lupus pipeline Notable movements in the SLE pipeline Overall increase in the number of late-stage candidates B-cell directed therapies are leading the way Lack of industry-sponsored clinical trials conducted in Japan Compounds recently discontinued Orencia (abatacept; Bristol-Myers Squibb) Apremilast (CC-10004; Celgene) NNC-0152-0000- Gusperimus trihydrochloride (NKT-01; Nippon Kayaku) MEDI-546 TARGET PRODUCT PROFILE Off-label treatments are the gold-standard therapies for SLE Comparator one: Rituxan/MabThera (rituximab; Biogen Idec/Roche) Comparator two: CellCept (mycophenolate mofetil; Roche/Vifor Pharma) Target product profile versus current level of attainment CLINICAL TRIAL DESIGN IN SYSTEMIC LUPUS ERYTHEMATOSUS Regulatory guidance on clinical trial design FDA finally publishes full formal industry guidance Summary of formal FDA guidance for industry in SLE Summary of FDA guidance for industry in lupus nephritis EMA guidelines Similarities can be seen in recent trial designs Standard of care Endpoints Variations in disease activity create a challenge Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) The British Isles Lupus Assessment Group (BILAG) European Consensus Lupus Activity Measure (ECLAM) Systemic Lupus Erythematosus Activity Index (SLAM) Measurement of flares Extent of organ damage is critical to assessing global systemic lupus erythematosus disease activity Rheumatologists are only moderately satisfied with current treatment efficacy measurements Movement towards composite endpoints Quality of life measures used as secondary endpoints Steroid-sparing effects Future of lupus trial design More stringent subsetting of patients INNOVATIVE EARLY-STAGE APPROACHES Biologics make up the majority of the early-stage pipeline Interferon inhibitors moving through the pipeline Cluster of differentiation drug candidates are seen in all phases of development CD20 product still in development for lupus Bortozemib: proteasome inhibitor shows early potential in lupus nephritis THE FUTURE OF DISEASE TREATMENT IN SYSTEMIC LUPUS ERYTHEMATOSUS Targeted therapies to reduce dependence on steroids Identification of biomarkers will aid in development and treatment BIBLIOGRAPHY Journal papers Websites Datamonitor reports Other APPENDIX A: SURVEY INFORMATION Physician research methodology The survey questionnaire APPENDIX B Contributing experts Report methodology About Datamonitor The Datamonitor Group is a world-leading provider of premium global business information, delivering independent data, analysis and opinion across the Automotive, Consumer Markets, Energy & Utilities, Financial Services, Logistics & Express, Pharmaceutical & Healthcare, Retail, Technology and Telecoms industries. Datamonitor's market intelligence products and services ensure that you will achieve your desired commercial goals by giving you the insight you need to best respond to your competitive environment. View more research from Datamonitor at http://www.fastmr.com/ About Fast Market Research Fast Market Research is an online aggregator and distributor of market research and business information. We represent the world's top research publishers and analysts and provide quick and easy access to the best competitive intelligence available. For more information about these or related research reports, please visit our website at http://www.fastmr.com or call us at 1.800.844.8156. # # # Fast Market Research is an online aggregator and distributor of market research and business information. We represent the world's top research publishers and analysts and provide quick and easy access to the best competitive intelligence available. End
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