Savient BLA Gets Priority Review

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By: Tim Wright

Editor-in-Chief, Contract Pharma

The FDA has accepted Savient Pharmaceuticals’ BLA for pegloticase, a novel biological drug for treatment-failure gout (TFG) patients. The FDA also granted Savient’s BLA a priority review status which accelerates the review period to six months. This 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. The target date for an FDA decisio...

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