FDA rejects Gilead’s HIV drug lenacapavir over glass vial concerns
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The FDA has rejected Gilead Science’s new drug application for a long-acting HIV drug over concerns with the proposed glass vials in which the drug would be stored, according to a press release.
On Wednesday, Gilead announced that the FDA issued a complete response letter regarding lenacapavir, an investigational, long-acting HIV capsid inhibitor that has been under review for the treatment of heavily treatment-experienced people with multidrug-resistant HIV infection. According to Gilead, the FDA raised concerns over the vials, which are made of borosilicate glass, and their compatibility with the lenacapavir solution. The company says they will continue to pursue the approval of lenacapavir to offer “a much-needed, new, long-acting treatment option” for people living with multidrug-resistant HIV.
“Gilead intends to provide FDA with a comprehensive plan and corresponding data to use a different vial type,” Merdad Parsey, MD, PhD, chief medical officer of Gilead Sciences, said in a press release. “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.”
Healio previously reported that the new drug application for lenacapavir was submitted by Gilead following the publication of data from a phase 2/3 trial that evaluated the safety and efficacy of lenacapavir in combination with an optimized background regimen. More recent data from an ongoing phase 2/3 study of heavily treatment-experienced people with multidrug-resistant HIV showed that 81% of participants who received lenacapavir in combination with an optimized background regimen achieved viral suppression at week 26.
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