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news.Savient Pharmaceuticals, a biopharmaceutical company, has submitted its biologics license application to the FDA seeking approval to market pegloticase in the US along with its request for a priority review.
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Savient’s filing includes data from both the six-month placebo controlled Phase III pivotal trials, as well as data from the open label extension study. The data set includes 101 patients with at least 12 months continuous treatment.
The two replicate, six-month, Phase III clinical trials for pegloticase were performed under the auspices of a special protocol assessment and pegloticase was granted orphan drug designation by the FDA.
Christopher Clement, president and CEO of Savient, said: “Filing the biologics license application (BLA) for pegloticase is a major milestone for Savient. This filing reflects our commitment to changing the paradigm of therapy available to the treatment-failure gout population and brings us one step closer to commercializing this drug and offering a solution to patients who suffer from this debilitating disease.”