What is rilonacept, and when did the FDA approve it?
Rilonacept (brand name Arcalyst) is an interleukin-1 (IL-1) inhibitor. The FDA approved rilonacept for two autoinflammatory indications: cryopyrin-associated periodic syndromes (CAPS) and, separately, treatment of recurrent pericarditis.
How did the FDA approvals differ by indication?
For CAPS, rilonacept is used in patients who have certain periodic fever syndromes driven by IL-1 signaling. For recurrent pericarditis, rilonacept is used to reduce the risk of recurrence after an initial episode or after a recent recurrence, depending on the prescribing context described in the FDA labeling.
What does the FDA label say about who can use it?
FDA-approved rilonacept use depends on the indication and patient eligibility described in the prescribing information, including age ranges and disease characteristics for CAPS versus recurrent pericarditis.
What side effects are associated with FDA-approved rilonacept?
Common risks discussed in rilonacept’s FDA labeling include infections (because it blocks IL-1–mediated inflammatory pathways), injection-site reactions, and changes in laboratory values. Specific adverse reactions and warnings are laid out in the boxed warnings/precautions and adverse reactions sections of the label for each indication.
Was approval based on clinical trial evidence?
FDA approval was based on clinical trials assessing whether rilonacept could control disease activity and reduce disease flares/recurrences in the labeled populations. The trials and endpoints used to support approval are included in the FDA review materials and labeling for each indication.
Where to find the exact FDA approval details (date, indication wording, label PDF)?
The most reliable place to confirm the exact FDA approval date, the final indication wording, and the required prescribing information is the FDA’s product labeling and approval history for Arcalyst (rilonacept). You can also cross-check through the FDA label PDF available on the FDA website or via the drug’s labeling page.
What if you meant a specific approval event (first approval vs later expansion)?
Companies sometimes get multiple FDA actions for the same drug (initial approval, then label expansions for additional subtypes, pediatric use, or new indications). If you tell me which indication you care about (CAPS vs recurrent pericarditis) or the year you saw, I can narrow down the exact approval record you likely mean.
Sources:
1. FDA – Arcalyst (rilonacept) prescribing information / label