Gilead Submits FDA NDA for Lenacapavir

Gilead announced it has submitted paperwork for a new drug application (NDA) for Food and Drug Administration (FDA) approval.

Lenacapavir was developed in combination with other antiretroviral agents for the treatment of HIV in adults and pediatric patients weighing at least 35 kg with multi-drug resistant (MDR) HIV who are currently on a failing antiretroviral treatment regimen due to resistance

“Lenacapavir is an important breakthrough innovation with the potential to be transformative for people living with multi-drug resistant HIV who have very limited treatment options,” Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences, said.

The submission is supported by data from the Phase 2/3 CAPELLA trial, which evaluated the safety and efficacy of lenacapavir administered subcutaneously every six months in combination with an optimized antiretroviral background regimen.

The Capella study involved 36 adults who were diagnosed with multi-class HIV drug resistance, as well as a detectable viral load while on a failing regimen. The participants were randomized 2:1 and received oral lenacapavir or a placebo while continuing on their current failing regimen for 14 days. At the end of the two-week period, a statistically significant proportion of the group receiving the treatment had a viral load reduction of at least 0.5 log10 copies/mL from baseline. The lenacapavir group also had a greater mean change in viral load when compared to the placebo group.

"Lenacaprevir may be a substantial addition to our current antiretroviral therapy options," Jason Schafer, PharmD, MPH, BCPS AQ-ID, BCIDP, AAHIVP, FASHP, professor of Pharmacy Practice and vice chair of the Jefferson College Pharmacy Department of Pharmacy Practice, said. "As a first in class agent it has the potential to help those with considerable treatment experience and multi-class resistance. As an agent that can be administered every six months as a subcutaneous injection it may introduce new treatment and prevention options that patients have never had before.”

The therapy had no serious adverse effects and was demonstrated to be well-tolerated and altogether safe. The most common side effects that occurred were grade 1 or 2 injection site nodules (17%) as well as injection site swelling (21%), and no discontinuations of the medication occurred during the trial period.

Gilead plans to submit authorization applications for lenacapavir to the European Medicines Agency and other international agencies in the coming months.