The therapy would be the first capsid inhibitor and the only HIV treatment option administered every 6 months.
Gilead announced that it has submitted documentation for a new drug application (NDA) for approval from the Food and Drug Administration (FDA).
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 multidrug-resistant (MDR) HIV who are currently on a failed antiretroviral treatment regimen due to resistance.
“Lenacapavir is an important breakthrough innovation with the potential to be transformative for people living with multidrug-resistant HIV who have very limited treatment options,” said Merdad Parsey, MD, PhD, chief medical officer of Gilead Sciences.
The presentation 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 background antiretroviral regimen.
Capella's study involved 36 adults diagnosed with multiclass HIV drug resistance and a detectable viral load while on a failed treatment regimen. Participants were randomly assigned 2:1 to receive either oral lenacapavir or a placebo while continuing their current, unsuccessful regimen for 14 days. At the end of the two-week period, a statistically significant proportion of the treatment group 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 compared to the placebo group.
The therapy had no serious adverse effects and was shown to be well tolerated and completely safe. The most common side effects that occurred were grade 1 or 2 injection site nodules (17%) and injection site swelling (21%), and there were no discontinuations of the medication during the trial period.
Gilead plans to submit marketing authorization applications for lenacapavir to the European Medicines Agency and other international agencies in the coming months.
In: https://www.contagionlive.com/view/gilead-submits-fda-nda-for-lenacapavir