Score One For FDAAA: Uloric Approval Was Clinched By Post-Market Powers
This article was originally published in Pharmaceutical Approvals Monthly
Within the review teams at FDA, there is the sentiment that the broadened safety authorities granted under the FDA Amendments Act allow the agency to approve drugs that it previously would have considered unapprovable, as an office director in the Center for Drug Evaluation and Research makes clear in the review documents for Takeda’s gout therapy Uloric (febuxostat).
You may also be interested in...
US FDA would not have approved Takeda’s Uloric but for a post-market safety study commitment. Now that the study is complete and suggests a potential increased risk of mortality, however, FDA doesn’t seem inclined to pull the product.
As US FDA weighs fate of Takeda’s febuxostat, advisory committee members suggest REMS to ensure prescribers have informed benefit/risk conversation with patients, but agency staff highlight design and assessment challenges for such a program.
Advisory committee will discuss whether CARES postmarketing trial showing 34% increased risk of cardiovascular death for febuxostat warrants market withdrawal, use restrictions, or new labeling for the gout drug.