FDA cautiously recommends approval of AZ's gout drug
- A panel of independent FDA advisers voted 10-4 in favor of approving AstraZeneca's (AZ) lesurinad, but the vote on approving the drug's safety profile was less positive.
- The main problem is that of two doses tested--200 mg and 400 mg---the higher dose was more effective at treating gout, but associated with risk of renal and cardiovascular issues.
- Therefore, AZ is only seeking approval for the lower dose, which can be used with a generic drug to address gout symptoms.
Lesurinad is a selective uric acid reabsorption inhibitor, which is designed to normalize acid excretion and reduce serum levels. It's a mode of action, which makes sense. The surprise was the high level of serious adverse events, which forced AZ to go with the lower dose.
Even at the lower dose, there are safety concerns, and it is this set of concerns which led to a vote of 7-6 with one abstention when it came to recommending approval of the safety profile.
Not only will AZ have to conduct post-marketing studies on lesurinad, which will be marketed as Zurampic, but there is a good chance that this drug will come with a black box warning. Despite this, analysts are optimistic, as reported last week, with projected revenues of $350 million by 2020.
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