Biopharmaceutical company Gilead Sciences submitted a new drug application to the U.S. Food and Drug Administration on Monday. Gilead is seeking approval of the drug lenacapavir, a long-acting HIV inhibitor, which is under clinical study.
The drug, which is an injection, is to be specifically used by people with multi-drug resistant HIV. Lenacapavir inhibits HIV, specifically HIV-1, by interfering with the virus’ replication process.
As part of the application, the FDA received data from the company on the safety and effectiveness of lenacapavir when taken every six months along with a regimen of antiretroviral medications. The company's data showed that there was an 88 percent efficacy in reducing viral load.
“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,” said Dr. Merdad Parsey, chief medical officer at Gilead, in the release. “The filing moves us 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.”
No adverse events in study participants were noted 14 days after they were injected with the drug. The most common side effect found was a reaction at the injection site.
Gilead plans to present its findings during the 11th Annual International AIDS Society Conference on HIV Science next month.
The drug received “Breakthrough Therapy Designation” from the FDA in May 2019. According to Gilead, lenacapavir’s development comes from an attempt to find proper treatment for those who may have resistance or intolerance to current antiretroviral treatments.
Gilead said it plans to submit authorization applications to the European Medicines Agency and other global bodies soon.