Kiniksa’s Arcalyst (rilonacept) Receives the US FDA’s Approval for the Treatment of Pericarditis

March 19, 2021 Auto Bot approval, FDA, Kiniksa, receives, regulatory, Treatment 0

Shots:

  • The approval is based on the P-III RHAPSODY trial involves assessing Arcalyst (SC, qw, 300mg followed by 160mg) vs PBO in adults and children aged ≥12yrs. in a ratio (1:1) with recurrent pericarditis
  • The result showed a 96% reduction in the risk, with pain- free or minimal pain days (92% vs 40%), sustained reductions in both reported pain and inflammation as early as the first dose & improvement in clinical outcomes
  • Arcalys (rilonacept) is a recombinant dimeric fusion protein that blocks IL-1α and IL-1β signaling and is expected to be available in Apr’21. Additionally, the company launches the One Connect patient support program to assess patients on their treatment journey

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Kiniksa

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