FDA approves 2015's 45th new drug, AstraZeneca's gout med
- The FDA has approved AstraZeneca's (AZ) Zurampic (lesurinad) for treatment of hyperuricemia in combination with an XOI. Hyperuricemia, or high levels of uric acid in the blood, is associated with gout. Zurampic boosts the ability of the kidney to excrete uric acid by limiting transport proteins involved in reabsorbing uric acid into the kidney.
- The approval is contingent on AZ conducting post-marketing studies to further assess renal and cardiovascular safety. Zurampic carries a black box warning for the risk of acute kidney failure.
- Zurampic is the 45th new drug approved by the FDA this year, a record for the agency.
When the FDA's advisory committee met in October and recommended approval of Zurampic, there were concerns over the drug's side effects. Between the two doses tested (200 mg and 400mg), the higher dose was more effective at treating gout, but carried with it a higher risk of renal and cardiovascular issues.
Toward this end, the FDA has required that AZ conduct a postmarketing study to further examine this risk.
Zurampic's safety and efficacy were evaluated in three randomized, placebo-controlled studies involving 1,537 patients. The drug was administered in combination with an XOI and proved effective in reducing serum uric acid levels compared to the placebo.
On the downside, the higher dose of Zurampic increases the risk of adverse events, prompting the FDA to issue a black box warning with the drug.
Analysts are optimistic about Zurampic's prospects though, with revenue estimates from Thomson Reuters Cortellis in the $350 million range.