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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