FDA Grants Kiniksa Expedited Approval Pathway for Recurrent Pericarditis Community

Sefton Eisenhart
Sefton Eisenhart

TREND is very excited to have contributed to Kiniksa’s application for Breakthrough Therapy designation, which was awarded by the FDA for rilonacept for the treatment of recurrent pericarditis. The drug is a weekly, subcutaneous injection for the treatment of recurrent pericarditis.

By establishing strong relationships with the recurrent pericarditis community, conducting interviews, and analyzing their conversation data, TREND was able to create a Community Impact Report illustrating the profound impact of the disease on patients and caregivers. This real-world data helped Kiniksa demonstrate evidence of disease burden, quality of life issues, and an urgent need for improved treatments.

“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,” said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa.

Breakthrough Therapy designation is a process designed to expedite the development and review of drug candidates that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug candidate may demonstrate substantial improvement over available therapies on a clinically significant endpoint. It’s been a great policy innovation on behalf of the FDA because it helps get improved treatments to the people who need them the most. In this case, the recurrent pericarditis community is benefiting.

As one participant said, “It’s refreshing to hear that someone is actually interested in what we are going through as it’s easy to feel forgotten with a rare condition.”

“Kiniksa is enrolling RHAPSODY, a global, randomized withdrawal (RW) design, pivotal Phase 3 clinical trial of rilonacept in patients with recurrent pericarditis in the U.S., Australia, Israel, and Italy. The primary efficacy endpoint is time-to-first pericarditis-recurrence in the RW period. The Clinical Endpoint Committee will adjudicate all suspected pericarditis recurrences for inclusion in the primary efficacy endpoint analysis. Top-line data are expected in the second half of 2020.”

Trend is proud to have played a small role in this wonderful progress. We look forward to continued work  with communities and companies to accelerate the pace of discovery and delivery of improved treatments.