Could a long-lasting HIV treatment option be on the way?
According to HIVPlusMag, Gilead Sciences submitted a new drug application on Monday, June 28, with the U.S. Food and Drug Administration. The pharmaceutical company is looking to get its drug lenacapavir approved.
Lenacapavir is a long-acting HIV inhibitor that attacks HIV, and specifically HIV-1, and prevents it from replicating itself. The drug was granted Breakthrough Therapy Designation in May of 2019 and has been highly watched and anticipated in the medical field.
Lenacapavir is currently in clinical studies, and showing good results. In order to apply for approval to distribute the drug to the public, Gilead had to supply data about the trials. If taken correctly, meaning every six months and with a supporting regiment of antiretroviral medication, lenacapavir can be 88 percent effective in reducing someone’s viral load. Though, there was one common side effect where a reaction, such as a rash, would happen at the injection site.
“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, Gilead’s chief medical officer, said in a press statement. “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.”
According to Business Wire, Gilead Sciences isn’t just applying the drug to the FDA. The company will also present its findings on lenavapavir at the 11th Annual International AIDS Society Conference on HIV Science. That will most likely cause a boost in support for the drug, but also inspire even more medical breakthroughs in the future.
Gilead says it plans to also submit applications with the European Medicines Agency and other international health organizations in the future.