Savient Pharmaceuticals, Inc announced that the US Food and Drug Administration (FDA) has accepted for review the company's Biologics License Application (BLA) for pegloticase, a novel biological drug for treatment-failure gout (TFG) patients.
The FDA also granted the company's BLA with a priority review status which accelerates the review period to six months. A priority review designation is assigned to drugs that are deemed by the FDA to have the potential to provide an important advancement in treatment or provide a treatment for which there is no adequate therapy available. Under priority review, the target date for an FDA decision on the pegloticase BLA is April 30, 2009.
The BLA submission is based on the two replicate, six-month phase-3 clinical trials, performed under the auspices of a special protocol assessment. Additionally, the company's BLA includes data from the open label extension (OLE) study for pegloticase, per the request of the FDA. The OLE study allowed those patients who completed the phase-3 trials to continue or begin receiving pegloticase for an extended period of time. The data set includes 101 patients with at least twelve months of continuous treatment. Pegloticase was previously granted orphan drug designation by the FDA.
Treatment-failure gout occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with allopurinol at the maximum medically appropriate dose or for whom allopurinol is contraindicated.
Savient Pharmaceuticals is a biopharmaceutical company engaged in developing and distributing pharmaceutical products that target unmet medical needs in both niche and broader markets.