Krystexxa 2010 Approval – Savient New Gout Drug FDA Approved – A new drug to help relieve gout suffers who have not responded to previous treatments has been approved by the Food and Drug Administration. The drug is called Krystexxa and is manufactured by Savient Pharmaceuticals Inc. of East Brunswick, N.J. It had a bumpy ride to gaining approval, after it was denied approval in August of 2009 following manufacturing problems. The problem was found that the drug differed between what was shown in clinical trials and what the manufactured product.
Gout is common in men, posy menopausal women and people with kidney problems. It occurs due to excess metabolic waste, such as uric acid. This uric acid makes it way into the bloodstream, and into joints and soft tissue. This causes problems such as redness, swelling, heat, pain and stiffness in the joints.
Gout is commonly associated with rich foods, however, it is more likely to occur from obesity, high blood pressure, high cholesterol and diabetes.
The conventional treatments include the drugs allopurinol and febuxostat, both of which inhibit the enzyme xanthine oxidase, which produces uric acid from DNA in food. Krystexxa, known generically as pegloticase, is an enzyme that acts directly on uric acid, converting it into harmless chemicals that are excreted in the urine. The drug is given by an intravenous infusion every two weeks.