Global biotherapeutics leader CSL Behring today announced that results were published in the New England Journal of Medicine (NEJM) from the COMPACT study, a pivotal Phase III study evaluating the safety and efficacy of CSL830 (a novel, investigational, self-administered, subcutaneous C1-Esterase Inhibitor [C1-INH] Human replacement therapy) for the prevention of HAE attacks. The study met its primary efficacy endpoint, significantly reducing the time-normalized number of HAE attacks. In addition, the study met its secondary endpoints, including the responder rate (patients who had at least a 50% reduction in their attack rate) and the number of rescue medication uses. If approved by the FDA, CSL830 would be the first and only subcutaneous preventative therapy for HAE.
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For the millions who suffer from Gastroesophageal Reflux Disease (GERD), a study published today in the New England Journal of Medicine (NEJM) provides clinical evidence of safety and effectiveness for a new, FDA-approved medical device. Torax Medical’s LINX® Reflux Management System was studied in a controlled, prospective, multicenter trial involving 14 U.S. and European medical centers as part of the FDA pre-market approval process. The patients were evaluated before and after treatment to determine the effect of the LINX System on their GERD using pre-defined success criteria, which included reduction of esophageal acid, improvement in quality of life and elimination of reflux medications.
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Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, reported that The New England Journal of Medicine today published results from Cohort B of The PARTNER Trial, which studied the Edwards SAPIEN transcatheter heart valve for the treatment of severe aortic stenosis. The results of the trial successfully met the primary endpoints of all-cause mortality and mortality plus repeat hospitalization.
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