Drug For Treatment Of Lupus On The Verge Of Being Approved By FDA
November 18th, 2010 - 8:47 pm ICT by GDBy Meena Kar
Nov 18, (THAINDIAN NEWS) Benlysta moved one step closer to being approved by the FDA on Tuesday when the FDA panel voted in its favor. If approved finally, it will be the first time that a medicine in the class of a drug has been approved for the treatment of the highly misunderstood and unrecognized lupus disease. The FDA will announce on December 9 its decision on the commercialization of the drug. The drug has been developed by Human Genome Sciences and Glaxo SmithKline. Both the companies came together to conduct the trial of the drug and it turned out to be 30% effective in the treatment of lupus. If approved the drug could hit US markets in 2011 according to some reports.
The FDA advisory panel voted in favor of Benlysta by a significant margin of 13-2. Considering that the FDA is known for approving drugs that are favored by outside panels, Benlysta could easily see the light of the day soon. The analysis by the FDA scientists raised some questions about the benefits and side-effects of the drug.
Among some of the adverse effects that were discussed in the panel meeting, it was highlighted that some of the patients treated with the drug had committed suicide. Another point that David Blumenthal of Case Western Reserve University highlighted was that one of the two key trials of the drug did not involve the patients in the United States. At the end of the panel meeting, however, the panelists were almost unanimous in voting in favor of the benefits and safety of the drug. Lupus is a somewhat overlooked disease the affects the immunity of a person and in worst cases can also lead to death.
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Tags: adverse effects, advisory panel, case western reserve, case western reserve university, commercialization, david blumenthal, fda, fda panel, fda scientists, glaxo smithkline, human genome sciences, immunity, kar, lupus, lupus disease, meena, panelists, treatment of lupus, verge, western reserve university