US Approves AstraZeneca’s Zurampic Gout Drug
Swedish drugmaker AstraZeneca has gained approval from the US Food and Drug Administration (FDA) to market Zurampic, a treatment for gout, the debilitating form of inflammatory arthritis caused by raised levels of uric acid, or hyperuricemia, in the blood.
Zurampic works by inhibiting the urate transporter responsible for the majority of the renal reabsorption of uric acid. It has been approved in combination with a xanthine oxidase inhibitor (XOI) for treating hyperuricemia in patients who have not managed to reduce their uric acid levels with an XOI alone.
When used with XOIs allopurinol or febuxostat, the therapy is said to provide a dual mechanism to increase excretion and decrease production of uric acid, enabling more patients with inadequately controlled gout to reach their treatment goals.
The FDA approval is based on data from three phase III studies. Lawrence Edwards, chairman and CEO of the Gout and Uric Acid Education Society, said a new approach to treating the disease is long overdue as there has been limited therapy innovation over the last 50 years.
Zurampic is also under review in the EU as well as other undisclosed territories. On Dec. 18, the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended the drug’s authorisation.
