AstraZeneca's Gout Dilemma: Should Smaller, More Frequent Lesinurad Dose Be Studied?
FDA is concerned about product's narrow therapeutic index, but advisory committee says it’s not an issue for approval; could this be addressed in post-marketing trial?
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Lower dose of oral, uric acid transporter inhibitor shows good efficacy in two of three Phase III trials, but renal safety risk appears to limit lesinurad’s potential market – if it gets approved at all.
The $1.26 billion buyout comes as the pharma is looking to bolt-on acquisitions to help offset recent late-stage pipeline disappointments and sees Ardea’s lesinurad as a potential improvement in gout therapy, an estimated $2 billion global market.
Cell and gene therapy product activities also have increased CBER’s workload significantly and strained staff, the agency tells industry representatives.