December 22, 2015: FDA has approved AstraZeneca’s (AZN) new drug for Gout named Zurampic, but requires AstraZeneca to conduct a post-marketing study on its effect on kidneys and cardiovascular systems. The drug would also need to have a boxed warning about the risks of Kidney failure.
What is Gout?
Gout is a form of arthritis caused by the presence of excess Uric Acid in Blood, which then gets accumulated as Uric Acid crystals near joints, resulting in inflammation and severe pain. When either body produces more Uric Acid than is normal, or when kidneys fail to excrete the excess Uric acid, the concentration of Uric Acid in the blood increases, resulting in a condition called Hyperuricemia.
Zurampic, chemically known as lesinurad, helps kidneys excrete the excess Uric Acid faster. In the drug trials, Zurampic was given in combination with Xanthine Oxidase Inhibitor (XOI). A Xanthine Oxidase Inhibitor also helps reduce the level of Uric Acid by inhibiting the function of an enzyme that helps convert Xanthine to Uric Acid.
The above therapy helps reduce the Uric Acid concentration in blood by both lowering its production and by also helping Kidneys remove the excess Uric Acid. Few adverse events recorded earlier included renal failure, which was higher when Zurampic was either prescribed in higher dose amount or when it was not given in combination with a XOI.
In Phase III trials, Zurampic 200 mg and 400 mg variants were analyzed for efficacy and safety. Earlier in October 2015, findings presented to the FDA suggested that the efficacy of the 200 mg drug in treating Gout was proven in two out of three studies conducted. The higher dose variant was more effective but also had much higher risks of adverse events. Risks were higher when a XOI was not given along with Zurampic. In light of these findings, physicians who prescribe Zurampic for Gout may consider starting a patient with a lower dose variant along with a XOI, before suggesting a stronger dosage regimen.
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