A CRL later, Gilead clears clinical hold on next-gen HIV drug — after finding a new glass vial for it
Back in late December, the FDA flagged concerns about the glass vials Gilead used to contain its experimental HIV therapy lenacapavir, citing risks of forming sub-visible glass particles in the drug solution.
Those issues were serious enough to trigger a clinical hold on 10 trials — and ultimately a rejection.
Two months after the complete response letter, Gilead said it’s finally found a solution that satisfies the FDA, which is lifting the clinical hold.
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