AstraZeneca's Zurampic received the green light from the United States Food and Drug Administration (FDA) on Dec. 22. The drug is used to reduce high levels of uric acid in the blood associated with gout.
Zurampic, also known as lesinurad, is used in combination with a xanthine oxidase inhibitor (XOI) or febuxostat, a drug already approved to lessen the production of uric acid in the body. The newly approved drug inhibits the function of transporter proteins involved in uric acid reabsorption in the kidneys, aiding in the excretion of uric acid from the body.
"Zurampic provides a new treatment option for the millions of people who may develop gout over their lifetimes," said Badrul Chowdhury, head of the Pulmonary, Allergy and Rheumatology Products division of the FDA. He also said controlling hyperuricemia, or the high concentration of uric acid in the blood, is crucial to the long-term cure for gout.
Safety And Effectiveness Of Zurampic
The FDA evaluated the safety and effectiveness of Zurampic after seeing the results of three randomized, placebo-controlled studies on 1,537 patients with gout for one year. The patients treated with the new drug combined with an XOI had lower serum uric acid (sUA) levels compared to the control group.
The study was called "Combination Treatment Study in Subjects with Tophaceous Gout with Lesinurad and Febuxostat" or CRYSTAL. It was a 12-month study across North America, Europe, Australia and New Zealand. Researchers evaluated Zurampic in two dosages (200 mg or 400 mg) in combination with 80 mg of XOI in patients who have one tophus or deposits of uric acid crystals in joints.
In June, AstraZeneca further presented an abstract of its analysis of its Phase III clinical trial. The analysis included the examination of the link between greater reduction of gout flares and lower sUA levels in patients. Researchers found that patients who obtained the lowest sUA levels experienced greater reduction in flares.
"While no oral agent has demonstrated a beneficial effect on flares in 12-month randomized controlled clinical trials, this analysis showed that over time – as lower sUA levels were maintained – flares decrease and tophus area reduced," said Johan Hoegstedt, Global Medicines Leader for Zurampic.
Gout: A Chronic Form Of Arthritis
Gout is a serious, chronic and debilitating form of inflammatory arthritis caused by deposition of uric acid crystals in tissues and fluids in the body. When the body overproduces or under excretes uric acid, it will circulate in the body and will form crystal deposits in the body's joints in time.
Typical symptoms of gout include excruciating pain in the hands or feet, red or swollen joints and inflammation. Flare ups respond well to treatments such as the intake of painkillers and diet changes, but repeated bouts of acute gout may lead to a degenerative form of arthritis called gouty arthritis.
In the U.S., an estimated 8.3 million individuals suffered from gout between 2007 and 2008, with a 1.2 percent increase in prevalence in the past two decades. The prevalence is higher in men than in women. Diet changes and weight loss are seen as most effective in lowering the risk of gout bouts.
Photo: Guian Bolisay | Flickr
