FDA rejects Gilead’s next big HIV drug over glass vial issues
Gilead on Tuesday received a rejection letter for its latest potential first-in-class HIV drug, as the company said the FDA cited Chemistry Manufacturing and Controls (CMC) issues relating to the compatibility of lenacapavir with its proposed container vial.
Regulators previously slapped a clinical hold on 10 trials studying injectable versions of the experimental HIV treatment, known as lenacapavir, due to concerns that vials made of borosilicate glass could lead to the formation of sub-visible glass particles in the solution.
“Gilead intends to provide FDA with a comprehensive plan and corresponding data to use a different vial type,” Gilead CMO Merdad Parsey said in a statement. “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.”
On the positive side for Gilead, the FDA did not request any new clinical trials in its CRL. Analysts previously estimated that lenacapavir sales will reach almost $900 million by 2026, according to Evaluate.
Gilead’s submission to the FDA was based on data from a Phase II/III trial, which evaluated the safety and efficacy of lenacapavir administered subcutaneously every six months in combination with an antiretroviral background regimen in heavily treatment-experienced people with multi-drug resistant HIV-1 infection.
After a year’s worth of data, Gilead said the findings demonstrated that lenacapavir “achieved high rates of virologic suppression and clinically meaningful increases in CD4 counts in people living with HIV whose virus was no longer effectively responding to their current therapy.” The most common adverse events in the study were injection site reactions (63%), nausea and diarrhea (13% each), and Covid-19 (11%).
Gilead’s been working on lenacapavir, an HIV-1 capsid inhibitor, for both the treatment and prevention of HIV-1 infection. While most antivirals act on just one stage of viral replication, the company says lenacapavir is designed to inhibit HIV-1 at multiple stages of its lifecycle. If approved, it would be the first HIV capsid inhibitor on the market.
Back in March, the company also signed a co-development pact to study its next-gen HIV candidate in combination with Merck’s islatravir.
However, Merck slammed the brakes on its program in November after investigators flagged a drop in immune cell counts that an external committee determined was related to islatravir. The FDA placed an official clinical hold on the experimental treatment earlier this month.