FDA approves Savient's replicate Puricase phase 3 trials for treatment of gout

By Lisa Kerner

Erie, Pa., May 3 - The Food and Drug Administration has approved a Special Protocol Assessment for Savient Pharmaceuticals, Inc.'s two replicate phase 3 clinical trials for its lead drug, Puricase (PEG-uricase) for the treatment of gout.

Patient dosing is expected to begin in May.

"Because our approach to the treatment of gout is novel, upfront agreement with FDA on the registration studies became a crucial component of our development strategy," chief medical officer Zeb Horowitz said in a company news release.

Savient said the phase 3 program is designed to compare the safety and efficacy of Puricase (PEG-uricase) administered by two-hour intravenous infusion every two weeks or every four weeks versus a placebo infusion, over a six-month period.

The two trials are independently powered for the primary efficacy endpoint, a responder analysis assessing the proportion of patients who have normalized plasma uric acid at month three and month six.

Secondary efficacy endpoints will include an assessment of the reduction in burden of gout tophi using digital photography, reduction in the frequency of gout flares and improvement in the count of swollen and tender joints.

The Short Form 36 and the Health Assessment Questionnaire-Disability Index will be used to record patient reported outcomes.

Savient is an emerging specialty pharmaceuticals company based in East Brunswick, N.J.

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