9/17/10 Big news for the estimated 90,000 Americans with gout who don’t find relief from current gout medications. The U.S. Food and Drug Administration, FDA, has approved a new drug called pegloticase, brand name Krystexxa, aimed specifically at helping those patients who don’t get better with conventional treatment.
According to answers sent via e-mail from FDA spokespersons Sarah Okada, MD, Clinical Team Leader, Rheumatology, Division of Pulmonary, Allergy, and Rheumatology Products and Badrul Chowdhury, MD, PhD, Director, Division of Pulmonary, Allergy, and Rheumatology Products, “People with severe chronic gout that has not been adequately controlled on other available therapies now have a therapeutic option that gives them a reasonably good chance of achieving control.”
Gout is a type of arthritis that occurs when uric acid builds up in blood, causing urate crystals to settle in joint, triggering gout attacks of intense pain, inflammation and stiffness. The condition affects more than six million people and more men get the condition then women. Obesity and diabetes are often associated with gout. Genetic factors and diet can also play a role in triggering the condition.
Until now, all gout medications on the market have been pills that are taken orally and prevent gout attacks by lowering uric acid in blood in one of two ways. Most commonly they decrease the production of uric acid by preventing purines, a type of protein produced naturally by the body and found in a variety of foods (such as beer and certain meats and beans), from turning into uric acid so it can’t crystallize in the joints. Other gout drugs increase the excretion of uric acid through urine.
“Patients with insufficient control, or who were not able to tolerate these medications, did not have many options, other than treatment of acute attacks of gout,” according to the e-mail from FDA spokespersons. “Krystexxa provides for the option of a different mechanism of action for patients with chronic gout who have not been adequately controlled with these other therapies, and may be uniquely helpful for treating patients with inadequately controlled severe disease that includes build up of lumps of uric acid crystals.”
Krystexxa also lowers uric acid, but in a different way. The medication is the first biologic developed for gout and requires an intravenous infusion, IV, every two weeks. This is because it involves an enzyme that wouldn’t be absorbed in pill form.
“Krystexxa is an enzyme that acts directly on uric acid, turning it into a different molecule, allantoin, that can be readily excreted in the urine,” according to the e-mail from FDA spokespersons.
Stage III clinical trials conducted by scientists at Duke University showed the drug successfully treated gout in about 40 percent of more than 200 study participants.
available in India also ?
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