Afamelanotide is FDA-approved as Scenesse for erythropoietic protoporphyria via a subcutaneous implant
Biallelic mutations in FDXR cause neurodegeneration associated with inflammation
To find out what else might be at play, we employed a mixture of public dataset analyses, in vitro and in vivo experimental models and discovered a potential driver: transcription factor NKX2-1 overexpression
Special Protocol Assessment The Federal Food, Drug, and Cosmetic Act directs the FDA to meet with sponsors, pursuant to a sponsors written request, for the purpose of reaching agreement on the design and size of clinical trials intended to form the primary basis of an efficacy claim in a New Drug Application (NDA) or a Biologic Licensing Application (BLA)
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The damage caused by SAP to the vascular endothelium is manifested as the release of inflammatory mediators and leukocyte adhesion, increased vascular permeability, changes in blood flow shear stress, microthrombosis, and microcirculatory disorders
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