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news.New York-based Regeneron Pharmaceuticals, an integrated biopharmaceutical company, has announced that its only marketed product ARCALYST (rilonacept) has met the primary and all secondary study endpoints of a second Phase 3 study (PRE-SURGE 2) in gout patients initiating allopurinol therapy.
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Rilonacept, also known as IL-1 Trap, is an agent that inhibits IL-1 (interleukin 1) and is indicated in the US for the treatment of Cryopyrin-associated periodic syndromes (CAPS), including familial cold auto-inflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS) in adults and children 12 and older.
The study aimed at evaluating whether ARCALYST was capable of preventing gout flares in patients starting therapy to lower uric acid levels.
Patients who received ARCALYST at a weekly, self-administered, subcutaneous dose of either 160 mg or 80 mg had a 72% decrease in mean number of gout flares compared to the placebo group.
These findings were consistent with those previously reported during the first, identical Phase 3 efficacy study (PRE-SURGE 1).
Regeneron said ARCALYST was generally well-tolerated, and the incidence of severe adverse events was similar in both arms of the study.
Arcalyst may also have significant potential as a co-treatment in allopurinol initiation for chronic gout since it aims to prevent joint pain flares during the first few months of therapy. If approved, it may generate up to $500m in annual revenue.