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Novartis’ Rhapsido Receives US FDA Approval for Symptomatic Dermographism

Shots:

  • The US FDA has approved Rhapsido (remibrutinib) for the treatment of adults with symptomatic dermographism (SD) inadequately controlled by H1 antihistamines
  • Approval was based on SD cohort data of the P-III (RemIND) trial, where Rhapsido (PO) showed higher rates of complete response from hives at Wk. 12 vs PBO as measured by the Total Fric Score (29.3% vs 14%), with responses seen as early as Wk. 2
  • Rhapsido (remibrutinib) is a highly selective BTK inhibitor that blocks the BTK pathway involved in histamine release, a key driver of hives & swelling

Ref: Globenewswire |   Image: Novartis  |  Press Release

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