A Food and Drug Administration panel of outside experts recommended Tuesday that the agency approve lupus drug Benlysta, developed by Human Genome Sciences Inc. and GlaxoSmithKline PLC.
The 13-to-2 vote increases the likelihood of the drug getting to patients with the autoimmune disease, making it the first new treatment in more than 50 years. The panel also voted that the data surrounding the drug demonstrated its effectiveness and its safety.
The FDA, which should make a decision by early December, isn't required to follow the advice of its panels, but usually does.
HGSI |
发表于 2010-11-16 19:18
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