Savient's Krystexxa Approved by FDA for Treatment of Gout
Gout is a kind of arthritis caused by uric acid build-up in the joints, causing swelling, pain, and stiffness. Research has found that certain lifestyle factors have made gout more prevalent in today’s society, so sufferers will be pleased to know that the FDA has improved a new gout drug called Krystexxa for treatment when conventional therapies fail.
Krystexxa Neutralizes Uric Acid Compounds that Cause Gout
Savient Pharmaceuticals of East Brunswick NJ manufactures Krystexxa, generically known as pegloticase. The drug, originally denied by the FDA last year due to manufacturing issues, will be approved for treatment in adults who do not tolerate current standard therapies, but will carry a black box warning regarding allergic and infusion reactions.
Doctors using Krystexxa for gout patients should “dispense a corticosteroid and an antihistamine to their patients beforehand to minimize the risk of such a [allergic] reaction” which occurred in about 25% of patients during the clinical trials.
The company will also be required to complete a post-approval study in 500 patients to further evaluate its safety.
Krystexxa lowers uric acid levels by metabolizing the substance into a harmless chemical that is excreted in the urine. The drug is administered to patients every two weeks by intravenous infusion.
About 5 million Americans suffer from gout, sometimes called “gouty arthritis”. Risk factors include alcohol intake, obesity, and eating an excessive amount of animal foods, particularly organ meats. Men, post-menopausal women and people with kidney disease are most often affected.
Currently approved medical treatments include colchicine, non-steroidal anti-inflammatory medications (NSAIDS), or steroids such as prednisone or cortisone. However, about 3% see no improvement with these conventional therapies, says Dr. Badrul Chowdhury, director of the FDA’s division of pulmonary, allergy and rheumatology products.
Savient Pharmaceuticals expects the drug to be available by prescription in the United States later this year. Sales of Krystexxa are estimated at more than $500 million in the U.S. and Europe.