FDA slaps a hold on Gilead's injectable HIV treatment over concerns about potential glass contaminants
The FDA is coming down on yet another therapy over concerns about glass particulates winding up in drug solution.
Regulators have slapped a clinical hold on 10 trials studying injectable versions of Gilead’s experimental HIV treatment lenacapavir, due to concerns that vials made of borosilicate glass could lead to the formation of sub-visible glass particles in the solution.
“We are committed to working diligently with FDA to resolve this glass vial compatibility quality issue and resume injectable lenacapavir dosing in the affected studies in a timely fashion,” CMO Merdad Parsey said in a statement.
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