Gilead Sciences (Nasdaq: GILD) has asked FDA for the second time in a year to approve the capsid protein inhibitor lenacapavir.
The drug won Breakthrough Therapy Designation from FDA in 2019 for HIV-1-infected individuals who are heavily treatment-experienced and have resistance to multiple drugs. The designation covered the potential use in tandem with other antiretroviral drugs.
In February, the FDA denied the approval of lenacapavir after concluding that the borosilicate glass vials containing the drug were incompatible with the medication as they could result in contamination with “sub-visible” glass particles.
Late last year, FDA placed a clinical hold on the use of the drug candidate in borosilicate vials for ongoing studies.
Foster City, California-based Gilead has also studied oral formulations of the drug.
Gilead included data on the drug used in vials made from aluminosilicate glass in its most recent new drug application. The resubmission includes substantial Chemistry Manufacturing and Controls data related to the drug held in alternative vials.
If approved, lenacapavir would be the only twice-yearly HIV-1 treatment.
“There are people with HIV who have severely limited treatment options due to resistance to multiple antiretroviral therapy classes,” said Dr. Jared Baeten, vice president, HIV clinical development of Gilead Sciences, in a statement. “We are committed to addressing unmet needs and recognize the urgency for filling the critical treatment gap for people with multi-drug resistant HIV whose virus is no longer effectively responding to their current therapy.”
Lenacapavir is designed to inhibit HIV-1 across multiple lifecycle stages and is not known to have cross-resistance to other drugs.
Prior studies have shown the drug to offer promise in heavily treatment-experienced people with multi-drug resistant HIV-1 infection.