Challenges in the Development of drugs for Systemic Lupus Erythematosus: A Regulatory Perspective
DOI:
https://doi.org/10.21423/JRS-V07DELVECCHIOKeywords:
Systemic lupus erythematosus, lupus, FDA, EMA, regulatory guidance, clinical developmentAbstract
Systemic lupus erythematosus (SLE) is a debilitating disease that affects at least 5 million people worldwide. Currently, there are limited approved treatment options for patients with SLE, and a great need remains for therapies to achieve important treatment goals such as reductions in flares, prevention of organ damage, clinical low disease activity or remission. The purpose of this article is to review the current health authority guidance for the development of drugs to treat SLE and discuss some of the challenges in the development of drugs for SLE from a regulatory perspective. Given the substantial number of failed late-stage clinical trials in this indication despite the inclusion of large numbers of subjects, reviewing the regulatory guidance and complexities surrounding the development of drugs for the treatment of SLE is crucial to understand the complexities of the disease itself and the challenges and limitations to conducting successful trials evaluating the impact of treatment of new agents in SLE. As only one new drug (belimumab, trade name BENLYSTA®) with a novel mechanism of action has been approved over the last six decades, the prescribing information for belimumab will be reviewed in the context of the guidance.
https://doi.org/10.21423/jrs-v07delvecchio
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