If approved, lenacapavir would be offered to HIV patients who have been heavily treated for the disease and have multi-drug-resistant HIV.
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Gilead Sciences is aiming to win regulatory approval for the first HIV-1 treatment administered twice per year. On Monday, the company submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor.
If approved, lenacapavir would be offered to HIV patients who have been heavily treated for the disease and have multi-drug-resistant HIV. The NDA is supported by data from the Phase II/III CAPELLA study assessing a subcutaneous formulation of the experimental drug.
In the Phase II/III study, lenacapavir hit its primary endpoint by demonstrating an 88% efficacy in reducing the viral load of at least 0.5 log10 copies/mL from baseline compared to placebo. Additionally, those who received lenacapavir achieved a statistically significantly greater mean decrease in viral load than those on placebo.
Gilead Sciences, which has three of the top four best-selling HIV drugs on the market, is planning to present complete data from the CAPELLA study at the International AIDS Society (IAS) Conference on HIV Science next month. Lenacapavir was generally well-tolerated. There were no serious adverse events related to the drug observed during the 14-day dosing period.
The NDA comes weeks after the world marked the grim milestone of HIV’s 40th anniversary. Since it first raised its head, the virus has taken the lives of more than 35 million people across the globe.
According to HIV data from the United Nations, in 2019, the most recent year with complete data, 1.7 million people were infected with HIV, and 690,000 died of AIDS-related causes. Currently, about 1.1 million Americans are living with HIV infection. It is estimated that 38,000 Americans are diagnosed with the infection each year, down significantly from peak infections.
Gilead Sciences’ lenacapavir is a novel investigational capsid inhibitor that interrupts the activity of HIV capsid, a protein that surrounds and protects the virus’ genetic material and essential enzymes. In in vitro studies, lenacapavir interrupts multiple distinct stages of the viral lifecycle, potentially preventing the virus from becoming infectious and gaining access to uninfected cells. The FDA granted Breakthrough Therapy Designation to lenacapavir in 2019.
Chief Medical Officer Merdad Parsey called lenacapavir a vital breakthrough innovation for HIV-1 patients who are multi-drug resistant and have few treatment options. The NDA filing moves the company one step closer to providing an “innovative treatment option that helps to address barriers to achieving viral suppression and meet the unmet needs of people living with multi-drug resistant HIV,” Parsey said in a statement.
Gilead plans to submit marketing authorization applications for lenacapavir to the European Medicines Agency and other regulatory agencies in the coming months.
Lenacapavir is being developed in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients. Earlier this year, Gilead Sciences and Merck teamed up to pair lenacapavir with Merck’s investigational nucleoside reverse transcriptase translocation inhibitor, islatravir. Both investigational drugs are potentially first-in-class medicines. It is thought the combination of the two medications could provide a new option of less frequent dosing for HIV patients.
