FDA approves gout treatment from Savient

WASHINGTON The Food and Drug Administration has approved a new treatment for gout, a painful condition that affects 3 million adults in the United States.

The FDA announced the approval of Savient Pharmaceuticals’ Krystexxa (pegloticase), a biotech drug for people who have not responded to or tolerated conventional therapies.

Gout results from buildup of uric acid in the body, resulting in needle-like crystals in the joints and soft tissue that can cause swelling, redness, pain, stiffness and heat. It often affects obese people; those with high blood pressure, high cholesterol and diabetes; people with kidney disease; and women after menopause.

Savient in May said that it would put itself up for sale following the approval of Krystexxa because it “would be the best way to realize the full commercial potential of Krystexxa on a global basis” and would be the best choice for the company.