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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