Persistence pays off for Merck & Co
The US Food and Drug Administration (FDA) has approved Merck & Co’s anaesthesia-reversing drug Bridion (sugammadex) at the fourth attempt. Although Bridion has been in use in Europe since 2008, US approval became an eight-year saga that would have been terminal for many drug candidates.
Additional clinical studies have assuaged the safety fears around brachycardia and anaphylaxis that were central to the previous rejections, but the approval remains contingent on Merck performing post-marketing safety studies in some specific patient subpopulations.
The active ingredient, a gamma-cyclodextrin with pendant carboxylate groups, selectively encapsulates and negates the effect of steroidal neuromuscular blockers such as rocuronium bromide (marketed as Esmeron and Zemuron). Patients can benefit from faster recovery after major surgery that requires muscle relaxants of this type.