The approval is based on positive data from the Phase 3 RAPHSODY trial, which evaluated treatment in older children and adults.
The US Food and Drug Administration (FDA) has approved rilonacept (ARCALYST) for recurrent pericarditis in adults and children ≥12 years of age.
The approval was granted to Kiniksa Pharmaceuticals.
Recurrent pericarditis is an autoinflammatory cardiovascular disease characterized largely by chest pain. The condition is associated with changes in electrical conduction and may lead to buildup of fluid around the heart, or pericardial effusion.
Conventional therapies include nonsteroidal anti-inflammatory drugs, colchicine, and corticosteroids, but many patients experience recurrent events due to inadequate response to medication or persistent underlying conditions.
“The approval of ARCALYST in recurrent pericarditis offers patients the first and only FDA- approved therapy for this devastating disease and also represents a transformational event for Kiniksa,” said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa in a statement.
“We look forward to launching ARCALYST for recurrent pericarditis with the support of our experienced commercial and medical affairs teams and, importantly, providing this breakthrough therapy to patients suffering with this debilitating disease as quickly as possible.”
Rilonacept is a weekly, subcutaneously-injected, recombinant fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) signaling.
FDA approval was based on positive data from the pivotal Phase 3 RAPHSODY trial, which showed that treatment with rilonacept led to rapid and sustained reductions in reported pain and inflammation as early as the first dose.
Furthermore, the median time to treatment response was 5 days with an overall 97% treatment response rate.
Patients who received rilonacept experienced a 96% reduction for a recurrent pericarditis event (Hazard ratio [HR], 0.04; P<.0001)
The investigators also reported that among the treated patients, 92% of the trial days were considered pain free or significantly pain-reduced—as compared with 40% of trial days with placebo (P<.0001)
The most common adverse events were reactions at the injection site and upper respiratory tract infections.
Rilonacept is planned for commercial launch in April 2021