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Savient Provides Update on Pegloticase BLA
Date:2/12/2009

  • Revised Prescribing Information. Upon further review, the Committee has determined that although both the every 4 week dose regimen and every 2 week dose regimen have met the primary endpoints demonstrating that the drug works as compared to the effects of placebo, the every 2 week dose regimen presents a much clearer path toward FDA approval due to the significant medically and clinically relevant benefit demonstrated as early as week 13 in the randomized clinical trials. Thus, the Company has determined to focus exclusively on the every 2 week dose regimen and will recommend this dosage for approval. Patients in the every 2 week dose regimen have demonstrated statistically significant clinical improvements including the reduction and resolution of gout tophi. Other statistically and clinically meaningful improvements included decreases in tender or swollen joint counts, reduction in flare incidences and frequency in months 4 to 6 of treatment, and meaningful improvements in pain reduction and health related quality of life measures at 6 months compared to placebo.

"I believe the recent amendments significantly enhance the overall application and better position the BLA to undergo a satisfactory FDA review. This is an exciting new therapy that, if approved, has the potential to have a meaningful impact on the patients who need it," said Dr. Simon. "Through our multi-faceted review, which included new analyses and further interpretation of data from a number of external experts, we have gained a greater understanding of the relative safety and efficacy of pegloticase and further clarification on the most appropriate uses for this product. Significantly, the data also confirms that a death imbalance of pegloticase does not exist."

Improved Understanding of the Cardiovascular Profile

In late November 2008, the Company enga
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SOURCE Savient Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
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