Four months after CRL due to contaminant worries, Gilead returns to FDA for next-gen HIV drug

2022-06-28

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Just shy of four months ago, Gilead’s next-gen HIV drug candidate lenacapavir got hit with a CRL over CMC issues involving the type of vials planned for use. Now, the pharma is headed back to the FDA for round two. Gilead announced Monday afternoon that it had refiled its NDA submission filled with new CMC data after the FDA essentially balked at borosilicate glass vials, originally used for the non-oral form of lenacapavir. The drug candidate, which recently won a positive opinion from Europe’s CHMP, is being developed for HIV-1 infection “in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection.” Many companies have run into particulate contamination issues, and this is not the first time Gilead has such a problem on its hands. Just last December, Gilead had to recall two lots of Veklury due to glass contamination issues. Regulators previously slapped a clinical hold on 10 trials — also last December — while studying injectable versions of the experimental HIV-1 capsid inhibitor HIV-1 capsid inhibitor, due to concerns that vials made of borosilicate glass could lead to the formation of tiny glass particles seeping into the solution. Gilead CMO Merdad Parsey said at the time that “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.” That hold was lifted in May, two months after the drug was initially rejected and after Gilead found a new solution with which the regulatory agency was content. Gilead’s VP of HIV clinical development Jared Baeten said in a statement that “There are people with HIV who have severely limited treatment options due to resistance to multiple antiretroviral therapy classes,” adding that the California company is committed to unmet needs. Baeten tells Endpoints News that Gilead currently has no plans at looking at lenacapavir outside of HIV treatment and prevention. And with the new progress, Gilead has started re-dosing patients in multiple clinical trials for HIV treatment — the basis of Gilead’s NDA, according to Baeten. On top of that, the restarted clinical trials include lenacapavir in participants as a pre-exposure prophylaxis, testing the drug as a method of HIV prevention. As for what makes the resubmitted NDA different from the first, Gilead said in a statement that “the NDA resubmission contains comprehensive CMC data to support the compatibility of lenacapavir with an alternative vial type made from aluminosilicate glass,” plus pre-clinical and clinical data. And now, the company is playing the waiting game to hear what FDA thinks, and whether the changes made are enough for the application to be accepted, analyzed and run through a new, yet-undisclosed PDUFA date. If it gets approved, lenacapavir will be the first HIV-1 capsid inhibitor HIV-1 capsid inhibitor on the market. Lenacapavir has been billed as Gilead’s next big thing in its HIV arsenal, given the drug’s potential to not only allow dosing just once every six months but block HIV-1 at multiple stages of the virus’s lifecycle and work to both treat and prevent infection. GSK’s ViiV Healthcare is also in the long-acting HIV treatment game, with its pre-prophylaxis injectable cabotegravir being the first HIV treatment to provide an alternative to a once-commonplace daily pill regimen.

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