Sugammadex MAA accepted by EMEA
Dutch drugmaker Organon, the human health care unit of Akzo Nobel, says that the European Medicines Agency (EMEA) has accepted its Marketing Authorization Application for sugammadex. The drug, which is a binder of selective muscle relaxants, has been specifically designed to reverse the effects of Esmeron/Zemuron (rocuronium bromide; made by Akzo), which is used as a general anesthetic during surgical procedures.
The firm said that the submission includes data from use of sugammadex in more than 1,700 patients, including the results of 10 Phase III trials. The results, which were presented at this year's annual Euroanesthesia conference in Munich, Germany, show that the drug reverses rocuronium-induced neuromuscular-blockade within three minutes.
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