Merck's Sugammadex Sails Through FDA Panel But Faces Post-Approval Studies
This article was originally published in The Pink Sheet Daily
Advisory committee suggests post-marketing epidemiological studies in higher risk patients to further assess risks of hypersensitivity, anaphylaxis and cardiac rhythm disorders with the neuromuscular blockade reversal agent.
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Merck must conduct studies to determine likely non-responders, assess occurrence of hypersensitivity or anaphylaxis, evaluate risk of cardiac arrhythmias, and study sugammadex's effects in morbidly obese patients.
Adequacy of data on risks of hypersensitivity/anaphylaxis and cardiac dysrhythmia with neuromuscular blockade reversal agent are focus of FDA advisory committee review.
Advisory committee agrees sugammadex data on routine reversal of neuromuscular blockade is clinically relevant.