Healthcare Business

Why This FDA Breakthrough Is a Big Deal for Recurrent Pericarditis Patients

Kiniksa Pharmaceuticals Ltd. (NASDAQ: KNSA) shares jumped on Wednesday after the firm announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for rilonacept for the treatment of recurrent pericarditis.

Recurrent pericarditis is a syndrome in which acute pericarditis returns after the agent inciting the original acute attack has disappeared or ceased to be active. The major clinical manifestations of acute pericarditis are chest pain, pericardial friction rub, widespread saddle-shaped or concave upward ST segment elevation on the electrocardiogram (ECG) and pericardial effusion.

The breakthrough therapy application was based on final data from an open-label Phase 2 clinical trial of rilonacept in a range of pericarditis populations that were included in a poster presentation at the American Heart Association (AHA) Scientific Sessions on November 16.

Currently, Kiniksa is enrolling Rhapsody, a Phase 3 clinical trial of rilonacept in patients with recurrent pericarditis in the United States, Australia, Israel and Italy. Top-line data are expected in the second half of 2020.

Sanj K. Patel, chief executive and board chair of Kiniksa, commented:

We are pleased that the FDA has granted Breakthrough Therapy designation for rilonacept for the treatment of recurrent pericarditis, a painful and debilitating autoinflammatory cardiovascular disease. The final Phase 2 data presented at AHA showed rilonacept treatment improved clinically meaningful outcomes associated with unmet need in recurrent pericarditis, including rapid resolution of pericarditis episodes, tapering and discontinuation of corticosteroids without pericarditis recurrence, reduction in recurrences of pericarditis episodes while on treatment, and improvement in quality of life scores. We continue to enroll RHAPSODY, our pivotal Phase 3 clinical trial of rilonacept in recurrent pericarditis, and expect top-line data in the second half of 2020.

Shares of Kiniksa Pharma traded up about 21% to $8.39 on Wednesday, in a 52-week range of $5.01 to $28.90. The consensus price target is $25.00.