The European Medicines Agency (EMA) has accepted AstraZeneca’s marketing authorization application for its investigational gout drug, which the company acquired through its acquisition of Ardea Biosciences.
AstraZeneca said that the EMA accepted its application for lesinurad 200mg tablets for the chronic treatment of hyperuricaemia in gout patients. Lesinurad is a selective uric acid reabsorption inhibitor (SURI) developed for treatment of hyperuricaemia in combination with xanthine oxidase (XO) inhibitors allopurinol or febuxostat in gout patients when additional therapy is warranted.
Gout is a serious, chronic and debilitating form of inflammatory arthritis. There are more than 15.8 million diagnosed cases of gout in major markets. Gout is caused by a metabolic disorder, known as hyperuricaemia (elevated sUA). Hyperuricaemia leads to the deposition of crystals in musculoskeletal structures such as the kidneys, joints and other tissues.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) will now weigh in on whether to approve the drug as an addition to standard gout therapy.
The filing comes on the back of positive data from three late-stage trials evaluating the drug as a combination therapy. In the trials, lesinurad met its primary endpoints of a statistically significant higher proportion of patients reaching the target serum uric acid (sUA) goal when used in combination with XO inhibitors. According to AstraZeneca, between 40 to 80 percent of patients do not achieve recommended sUA goals with current standard of care of an XO inhibitor alone.
Lesinurad works by inhibiting the uric acid transporter (URAT1) in the kidney, therefore increasing uric acid exctretion resulting in lower sUA. Combining lesinurad and an XO inhibitor provides a dual mechanism approach targeting both excretion and production of uric acid, which effectively lowers sUA and enables significantly more patients to achieve and maintain target treatment goals to control their disease.
However, the company previously announced that in two of its Phase III studies, lesinurad failed to beat out allopurinol in a secondary endpoint of reducing the number of gout exacerbations.
AstraZeneca obtained lesinurad in June 2012, through its $1.26 billion acquisition of Ardea Biosciences.
Source: AstraZeneca plc