FDA slams GSK's month­ly HIV in­jectable with CRL, cit­ing man­u­fac­tur­ing is­sues

HIV pa­tients will have to wait a while longer for a long-act­ing vi­ral sup­pres­sion reg­i­men as the FDA has re­ject­ed Vi­iV Health­care’s NDA for the month­ly in­jec­tion of cabote­gravir and rilpivirine.

Reg­u­la­tors hand­ed the GSK sub­sidiary a com­plete re­sponse let­ter days be­fore the orig­i­nal PDU­FA date on De­cem­ber 29. While Vi­iV had been ex­pect­ing a smooth sail to the fin­ish line based on glow­ing clin­i­cal re­sults, the CRL cit­ed con­cerns with chem­istry man­u­fac­tur­ing and con­trols.

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