AstraZeneca’s Saphnelo (anifrolumab-fnia) Receives the US FDA’s Approval for the Treatment of Moderate to Severe Systemic Lupus Erythematosus

August 2, 2021 Auto Bot approval, AstraZeneca, FDA, regulatory, Saphnelo, Systemic Lupus Erythematosus 0

Shots:

  • The approval is based on efficacy and safety data from the clinical development program, including two P- III TULIP trials and the P-II MUSE trial evaluating Saphnelo vs PBO in patients with SLE who are receiving standard therapy
  • The result from the trials showed a reduction in overall disease activity across organ systems, including skin and joints, and achieved a sustained reduction in OCS with both groups receiving standard therapy
  • Saphnelo is a mAb that binds to subunit 1 of the type I IFN receptor, further blocks the activity of type I IFNs and is under regulatory review for SLE in the EU and Japan. This marks the first regulatory approval for a type I IFN receptor antagonist for SLE

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