AstraZeneca has received Food and Drug Administration approval for Zurampic tablets for some patients with gout, a painful condition related to the body’s effort to deal with uric acid.
Zurampic, when combined with the current standard of care medicines provides a dual mechanism of action to increase excretion and decrease production of uric acid, aiding more patients not able to control gout, AZ reported.
Sean Bohen, executive vice president of Global Medicines Development and chief medical officer at AstraZeneca, said: “With the FDA approval of Zurampic, we are pleased to offer a new treatment option for the many patients who are suffering from the effects of gout and who are not reaching the recommended serum uric acid treatment targets with the current standard of care.
Gout affects millions of people around the globe, many of whom do not reach recommended treatment goals on XOIs, which decrease production of uric acid.
Dr. Lawrence Edwards, chairman and CEO of the Gout and Uric Acid Education Society (GUAES), said: “A new approach to treating gout is long overdue given there has been limited therapy innovation over the last 50 years. Combination therapy with Zurampic is an important addition to the medicines available to physicians that will help more gout patients reach their serum uric acid treatment targets, which may ultimately relieve their suffering from this painful disease.”
The drug is also under regulatory review in the European Union and other territories.
The DCA reported the most common adverse reactions in clinical trials were headache, influenza, increased blood creatinine, and gastroesophageal reflux disease.
Zurampic has a boxed warning that provides safety information for health care professionals, including the risk for acute kidney (renal) failure, which is more common when used without an XOI and with higher than approved doses of Zurampic.
The FDA is also requiring a postmarketing study to further evaluate the renal and cardiovascular safety of Zurampic.
AstraZeneca has administrative headquarters operations in Delaware and about 2,200 employees.
