FDA Panel Backs Human Genome's Lupus Drug
NEW YORK (
) --
Human Genome Sciences
(HGSI)
and
GlaxoSmithKline
(GSK)
won approval from a key drug panel on Tuesday afternoon, bringing the pair closer to gaining regulatory approval to sell the first new lupus drug in more than five decades.
TheStreet
biotech columnist Adam Feuerstein has been live blogging the Human Genome FDA panel event all day Tuesday.
>>Human Genome FDA Panel Live Blog
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The potential benefits of the Human Genome Sciences drug, Benlysta, outweigh the risks, the panel of outside advisers to the FDA decided in a 31-2 vote. Potential risks of using Benlysta include suicide, infection and cancer. The FDA is not required to follow the decision of the outside advisers, but it has done so with prior decisions.
Annual sales of Benlysta could reach above the $2 billion mark, according to several Street estimates.
Human Genome Sciences and GlaxoSmithKline now await an FDA decision by Dec. 9
-- Written by Eric Rosenbaum from New York.
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>>Human Genome FDA Panel Live Blog
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