Human Genome: FDA Panel Live Blog
WASHINGTON, D.C. (
Human Genome Sciences
(HGSI) brings its experimental lupus drug Benlysta in front of a U.S. Food and Drug Administration advisory panel today, a pivotal step in the company's efforts to market the first new lupus drug in about 50 years.
If approved, Benlysta is expected to be the first blockbuster drug to emerge from Human Genome's research labs, possibly generating peak sales greater than $2 billion. GlaxoSmithKline (GSK) will co-market Benlysta under a partnership agreement with Human Genome.
The FDA is asking its advisory panel Tuesday to consider the benefits and risks of Benlysta in patients with the autoimmune disease lupus. Human Genome Sciences conducted two, large phase III studies demonstrating greater overall patient response to treatment with Benlysta compared to placebo.
In a review of Benlysta posted Friday, FDA reviewers questioned the robustness of Benlysta's benefit and raised some safety concerns, including a potential higher suicide risk associated with the drug."Clearly there is a need for effective therapies in SLE
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