AstraZeneca’s Gout Treatment OK, But Post-Marketing Studies Needed
This article was originally published in The Pink Sheet Daily
FDA's Arthritis Drugs Advisory Committee recommends approval of lesinurad despite concerns about safety.
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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.
Virtual kick-off meetings may be necessary, but preparations continue in anticipation of the formal talks to reauthorize the prescription drug, generic drug and biosimilar user fee programs.
Agency officials can now discuss the ideas that have been accepted, though not in great detail.