Regeneron reported mixed results June 9 for its investigational gout therapy Arcalyst (rilonacept/IL-1 Trap). In the Phase III study PRE-SURGE 1, which evaluated the number of gout flares per patient over the first 16 weeks following initiation of allopurinol therapy, the interleukin-1 inhibitor met the primary and all secondary endpoints. Patients receiving 160 mg weekly experienced an 80 percent decrease in mean number of flares compared to placebo, and patients receiving the 80 mg dose experienced a 73 percent decrease. It was well-tolerated with no serious adverse events. The company plans to file Arcalyst in that indication in mid-2011 if data from two ongoing studies are successful. Both a second efficacy study and a 1,000-patient safety study are expected to report early next year. The second study reported June 9 evaluated the effectiveness of adding Arcalyst to the non-steroidal anti-inflammatory indomethacin in patients experiencing acute gout flare; the combination showed no pain benefit compared to the NSAID alone. Arcalyst will be the first of the new wave of gout drugs to take on the task of relieving painful flares that happen when uric acid lowering drugs start to affect serum uric acid levels (1Pharmaceutical Approvals Monthly, November 2009)
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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