FDA grants priority review for drug for treatment-failure gout
EAST BRUNSWICK, N.J. The Food and Drug Administration has given priority review to an approval application for a biologic treatment for treatment-failure gout, the drug's manufacturer announced Monday.
Savient Pharmaceuticals said that the FDA accelerated the view of the drug pegloticase to six months. The FDA gives priority review to drugs that it considers to have the potential to provide an important advancement in treatment or treat diseases for which no adequate therapy exists.
Treatment-failure gout occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with allopurinol.