PCSK9 'Groundhog Day': Amgen’s Repatha Gains FDA Panel Backing In High-Risk Groups
This article was originally published in The Pink Sheet Daily
Recommendation against broad use pending results from CV outcomes trial is a near repeat of advisory committee's deliberations a day earlier on Praluent. But Amgen drug gains one competitive advantage over Sanofi/Regeneron's PCSK9 inhibitor: a unanimous endorsement for use in homozygous familial hypercholesterolemia.
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Government Accountability Office also finds that US FDA review divisions are largely consistent in their assessment times after controlling for goal dates and expedited programs.
Virtual kick-off meetings may be necessary, but preparations continue in anticipation of the formal talks to reauthorize the prescription drug, generic drug and biosimilar user fee programs.
Agency officials can now discuss the ideas that have been accepted, though not in great detail.