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
The post Kiniksa’s Arcalyst (rilonacept) Receives the US FDA’s Approval for the Treatment of Pericarditis first appeared on PharmaShots.