FDA approves Arcalyst for recurrent pericarditis.- Kiniksa Pharma

Kiniksa Pharmaceuticals announced the FDA approved Arcalyst (rilonacept), a weekly, subcutaneously-injected, recombinant fusion protein that blocks interleukin-1 alpha and interleukin-1 beta signaling, for the treatment of recurrent pericarditis and reduction in risk of recurrence in adults and children 12 years and older. The commercial launch is expected in April 2021.The FDA approval of Arcalyst in recurrent pericarditis follows positive data from RHAPSODY, a pivotal Phase III trial of Arcalyst in recurrent pericarditis. RHAPSODY met its prespecified primary endpoint of time-to-first adjudicated pericarditis recurrence in the randomized withdrawal period and all major secondary efficacy endpoints with statistical significance. The data showed that Arcalyst treatment in the trial improved clinically meaningful outcomes associated with the significant unmet medical need in recurrent pericarditis. There were rapid and sustained reductions in both reported pain and inflammation as early as after the first dose. Median time to treatment response was 5 days, with a 97% treatment response rate. Patients randomized to Arcalyst experienced a 96% reduction in the risk for a recurrent pericarditis event (Hazard Ratio = 0.04, p<0.0001), with 92% of trial days being pain free or at most experiencing minimal pain, compared to 40% of trial days on placebo (p><0.0001). the most common adverse events were injection site reactions and upper respiratory tract infections. rhapsody data were published in the new england journal of medicine simultaneously with a late-breaking scientific presentation at the american heart association’s scientific sessions 2020.>