Most Recent Articles by Steve Duffy
Pooled data from two identical 12-week pivotal Phase 3 trials (N=1229) in patients with moderate to very severe COPD showed that the mean annualized rate of all COPD exacerbations was 0.47, 0.45, and 0.55 for revefenacin 175mcg/day, 88mcg/day, and placebo, respectively.
The FDA's designation was based on data from a Phase 2 placebo-controlled trial that demonstrated pamrevlumab could potentially address an unmet medical need for this condition.
The full findings from the study will be presented at a future scientific conference; Merck plans to include the data in a supplemental New Drug Application for Zerbaxa which will be submitted to the Food and Drug Administration.
In their Complete Response Letter, the FDA stated that they require more clinical data to support approval.
According to the Centers for Disease Control and Prevention (CDC), the 2017-2018 flu season was one of the most severe - excluding pandemics - on record.