FDA nod for Kiniksa’s Arcalyst in recurrent pericarditis

The US Food and Drug Administration (FDA) has approved Kiniksa Pharmaceuticals’ interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) inhibitor Arcalyst (rilonacept) for the treatment of recurrent pericarditis and reduction in risk of recurrence in adults and children 12 years and older.

Recurrent pericarditis is an autoinflammatory cardiovascular disease that often presents with chest pain, and is associated with changes in electrical conduction and build-up of fluid around the heart.

The FDA approval is based on positive data from the RHAPSODY trial in recurrent pericarditis. Data from this trial showed that Arcalyst treatment 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 of Arcalyst.

“The approval of Arcalyst in recurrent pericarditis is an extremely important achievement for those suffering from this disease as there can be significant impact on a patient’s physical and emotional health as well as quality of life,” said Dona Winnowski, president of the Pericarditis Alliance.

“The development and commercialisation of new medicines for underserved and severe diseases are essential, and this first FDA-approved therapy in recurrent pericarditis brings hope to patients and their families,” she added.