US FDA Panel Rejects Trelegy Ellipta COPD Mortality Claim; Worries Include Potential Overuse
Survival benefit seen in GlaxoSmithKline’s IMPACT study may be due to negative effects of abrupt withdrawal of inhaled corticosteroids for some patients instead of benefits of the triple-combination therapy itself, advisory committee members said.
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and are collaborating on a computational approach for assessing bioequivalence in inhaled generics. Their project aims to ease the USFDA approvals process for a drug class whose pharmacokinetic properties are notoriously difficult to observe.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
GSK wants labeling to reflect all-cause mortality results from the 10,355-patient IMPACT trial of the triple-combination therapy for COPD, but FDA questions whether the survival benefit was driven by the abrupt halt in inhaled corticosteroid treatment for some randomized subjects.