US Food and Drug Administration’s (FDA) Arthritis Advisory Committee (AAC) voted 10 to 4 to recommend the approval of lesinurad 200mg tablets for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor (XOI). All 10 who backed the drug, lesinurad, qualified their vote by urging the FDA to ask AstraZeneca for studies after the drug's launch to gauge its long-term effectiveness and safety.
Gout is a serious and debilitating form of inflammatory arthritis caused by hyperuricemia.
A majority of voting FDA panel members agreed lesinurad's benefit was modest, but meaningful. Those who voted against approval said the drug's safety profile precluded their support. Lesinurad was developed by Ardea Biosciences, which was acquired by AstraZeneca for $1.26 billion in 2012.
The FDA is not required to follow the recommendations of its advisers, though it most commonly does. AstraZeneca hasn't disclosed the agency's target decision date for lesinurad, but it generally comes within two months of a panel vote.
In Phase III trials, AstraZeneca tested two doses of the drug, 200 mg and 400 mg, finding that the former only met its efficacy goals in two of three studies, while the latter better treated gout but led to alarming renal and cardiovascular safety issues.
AstraZeneca is seeking approval only for the 200 mg version, but even the smaller dose had a safety overhang that dissuaded some members of the FDA's advisory group
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