The regulatory agency issued a complete response letter (CRL) to the company’s New Drug Application (NDA) for lenacapavir mentioning Chemistry Manufacturing and Controls (CMC) issues related to its compatibility with the proposed container vial.
Lenacapavir is a long-acting HIV-1 capsid inhibitor, developed to treat HIV-1 in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) infection.
Previously, FDA cited issues regarding the vials made of borosilicate glass as well as their compatibility with the solution and placed the injectable therapy on clinical hold.
Gilead Sciences chief medical officer Merdad Parsey said: “Gilead intends to provide FDA with a comprehensive plan and corresponding data to use a different vial type.
“We look forward to discussing this further with FDA over the coming months so that we can make this investigational new therapy available to people living with multidrug-resistant HIV as soon as possible.
“People living with multidrug-resistant HIV need new treatment options and we will continue to pursue approval of lenacapavir to offer a much-needed new long-acting treatment option for this population.”
In June last year, the company submitted the NDA for lenacapavir to treat HTE patients with multi-drug resistant HIV-1 infection.
Gilead’s application was based on the results obtained from the Phase II/III CAPELLA trial that assessed lenacapavir’s efficacy and safety.
In the trial, the drug was given every six months subcutaneously together with an optimised antiretroviral background regimen to HTE patients with multi-drug resistant HIV-1 infection.
The findings showed that the drug achieved clinically meaningful increases in CD4 counts and high rates of virologic suppression in HIV patients.
The most common adverse events observed in the CAPELLA study included Covid-19, diarrhea, and nausea.