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FDA rejects Schering-Plough's Bridion
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Schering-Plough's stock fell on the surprising news that the FDA rejected Bridion (sugammadex), a treatment to reverse muscle relaxation during general anesthesia. The FDA expressed concern over allergic reactions observed in some patients. However, an outside expert panel recommended the drug, and the EU also approved it earlier this week.
"We are surprised and disappointed with this action, especially given that sugammadex received a unanimous recommendation for approval by the FDA Advisory Committee on Anesthetics and Life Support in March of this year," said Thomas P. Koestler, Ph.D., executive vice president and president of Schering-Plough Research Institute. "We remain committed to bringing this important medical advance to those who are waiting for it in the United States, and plan to work with the agency to address the issues, which are primarily related to hypersensitivity/allergic reactions."
- check out this release for more
Related Articles:
EU approves Shering-Plough's Bridion
Schering-Plough wins an EC approval
Organon touts late-stage data for sugammadex
Comments
By Harvey Grove | Posted 2:19am | August 4, 2008
FDA rejection of a totally new anesthesia drug (by Schering) after it passed all reviews by the FDA panel of experts seems as though it is PUNISHMENT to Scvhering for withholding info on the ENHANCE study. One should have nothing to do with the other.
The side effects of Schering's product (mostly easy to control allergy) is less of a problem than either of the druge it will replace. In addition, the benefits are significant and provide more safety to the patient than any other similar use product in about 20 years. The removal of intubation tubes and allowing the patient to breath for himself in short order is more important than the easy to treat allergy that some patients may get. The action of FDA after considering the opinions of the panel of experts seems to be a punishment to Schering as opposed to providing safety for the patient.
By Anaesthesion | Posted 4:04pm | August 9, 2008
I think it is an absolutely prudent move to block this new reversal agent. There need to be bigger and better studies to prove efficacy before subjecting patients to sugammadex which is not a life saving drug. Apparantly it binds to steroidal neuromuscular blockers, but does anyone know if this binding can be displaced by other lipophilic agents used in anesthesia subjecting the patient to risk of reparalysis. There is also mention in one study about prolongation of QT interval (which led to black box warning of droperidol use as an anti-emetic). FDA needs to think more about this drug before releasing.
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