Another HIV drug clinical study was suspended by the U.S. FDA this time from Gilead

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Following Merck’s islatravir, another HIV drug in research has encountered a clinical suspension by the US FDA, this time from Gilead

On December 22, Gilead issued an announcement stating that as many as 10 clinical trials of its injectable HIV drug candidate lenacapavir were suspended by the US FDA

Merdad Parsey, chief medical officer of Gilead, said in a statement that the clinical suspension does not involve clinical trials of oral lenacapavir

Gilead also stated in its statement that during the clinical suspension period, all lenacapavir studies are not allowed to screen and enroll study participants, nor are they allowed to inject lenacapavir

The clinical studies affected by lenacapavir for injection range from the early stage to the late stage of development, including two phase 3 trials, all of which are currently on hold

Brian Abrahams pointed out that, first of all, most of the suspended studies are early and represent only a "small" market opportunity, "Even if the dose is skipped.

At the same time, in a later study, lenacapavir for injection was administered every 6 months

And Merck’s situation is obviously worse

But it needs to be pointed out that this is not the first time that Gilead has had a particle panic this month

Gilead did not explain how the glass particles appeared in the Veklury vial, and it is unclear whether the problem with lenacapavir is related to this

Reference source: Particulate problem prompts hold on 10 Gilead studies of HIV hopeful lenacapavir