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Enthusiasm following Benlysta's approval has died down, and there remains a considerable need for effective biologic therapies

With considerable remaining unmet needs for effective biologic therapies, companies developing pipeline candidates for systemic lupus erythematosus (SLE) should consider lessons from Benlysta (belimumab; GlaxoSmithKline) in order to maximize their future commercial potential. As the only biologic to have been approved for SLE in over 50 years, Benlysta is considered the benchmark drug, and key opinion leaders note that new agents in development must demonstrate equal or superior efficacy before they will achieve equivalent uptake with rheumatologists in the US and five major EU markets (France, Germany, Italy, Spain, and the UK). Although the approval of Benlysta was met with widespread enthusiasm, in daily practice only a moderate number of patients fit the criteria for its use. Indeed, the drug is mostly used for maintenance therapy. Furthermore, skepticism still exists, fueled by mixed efficacy and results in practice. Nevertheless, Benlysta has faced little competition as other therapies have so far failed to match its success in Phase III.


Following very promising Phase IIb results, anifrolumab (AstraZeneca) has been propelled to the forefront of SLE drug development. AstraZeneca has invested in two large-scale Phase III trials, and if anifrolumab demonstrates similar efficacy in these trials, the company will be able to benefit from a wide open SLE market, with minimal competition in its way. However, numerous promising candidates have previously failed to succeed in Phase III, including Anthera Pharmaceuticals’ blisibimod and Merck KGaA’s atacicept, both of which failed to meet the primary endpoint in their Phase III trials, putting further development of both drugs in jeopardy. As a result, success for anifrolumab is far from guaranteed in this difficult market, until additional data become available.


Datamonitor Healthcare’s SLE marketed and pipeline analysis compares the clinical and commercial attractiveness of marketed and pipeline candidates, providing an assessment of future product positioning and competitiveness in the marketplace.

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