Gilead’s Quad Makes It Through FDA Panel Review Despite Renal Safety Concerns
This article was originally published in The Pink Sheet Daily
Antiviral Drugs Advisory Committee votes 13-1 in favor of the four-drug-in-one HIV treatment. Panel members offer a host of suggestions for post-marketing studies, including determining the best means for detecting Quad-related renal injury early.
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The four-drug, single-tablet HIV treatment regimen was associated with higher rates of serious adverse events and study drug discontinuations due to renal events in the pivotal trials. FDA is seeking the Antiviral Drugs Advisory Committee’s views on renal safety and whether monitoring recommendations should be stricter than those proposed by Gilead.
Access to expedited regulatory pathways, marketing exclusivity and tax credits in exchange for enrolling and retaining diverse clinical trial populations could provide a ‘carrot’ to the ‘stick’ in US FDA guidance and legislative proposals; attorneys Sarah Thompson Schick and Winston Kirton also call for a re-examination of concerns about remuneration for trial participants.