Accelerating to Phase IV

By beginning a Phase IV confirmatory trial of Riquent abetimus before knowing whether the product has received accelerated approval, La Jolla Pharmaceutical Corp. is playing to FDA's concerns about sponsors meeting their Phase IV commitments. LJPC is neither stockpiling inventory, nor recruiting a sales and marketing staff ahead of its Oct. 16 PDUFA date. But last week, the company obtained an SPA for and began enrollment in an international Phase IV trial in 500-600 lupus patients with renal disease, which is double the size of its previous Phase III.

Should FDA not grant accelerated approval for Riquent, the company has no assurance that its new study could support a new NDA filing. Nevertheless, LJPC hopes that by starting the trial in a timely fashion, it is giving the agency some assurance that it will be completed...