The European Commission (EC) has granted Marketing Authorization for the first twice-yearly HIV therapy, Sunlenca (lenacapavir), developed by Gilead Sciences, the biopharmaceutical company announced in a press release.
As a first-in-class capsid inhibitor, Sunlenca is a twice-yearly HIV treatment for patients whose current therapy is no longer working, Gilead explains. The injection and tablets are intended to treat HIV in combination with other antiretroviral(s), particularly in adult patients who have developed multi-drug resistant HIV infection who are ineligible for a suppressive anti-viral regimen.
“Lenacapavir helps to fill a critical unmet need for people with complex prior treatment histories and offers physicians a long-awaited twice-yearly option for these patients who are at greater risk of progressing to AIDS,” said Jean-Michel Molina, MD, Université Paris Cité, Professor of Infectious Diseases and Head of the Infectious Diseases Department at the Saint-Louis and Lariboisière Hospitals.
“In the CAPELLA study, lenacapavir, in combination with other antiretroviral therapies, demonstrated sustained rates of virologic suppression and clinically meaningful CD4+ T-cell recovery in people with multi-drug resistant HIV. Lenacapavir provides an innovative long-acting HIV therapy option with the potential to transform the clinical landscape.”
According to Gilead Sciences, major improvements have been made in antiretroviral medication, however, there are still many crucial and urgent concerns for those living with HIV. This is especially true for HIV patients who have undergone numerous treatments, have few therapeutic options, and are unable to sustain virologic suppression due to resistance or difficulties adhering to a demanding regimen. This level of intricacy raises the likelihood of poor treatment adherence and failure, which emphasizes the need for a new treatment option that is effective against resistant viral variations and has a novel mechanism of action.
“The European Marketing Authorization is the latest milestone in the review of lenacapavir by a major regulatory authority. In July, the U.S. Food & Drug Administration (FDA) accepted for review the New Drug Application (NDA) resubmission for investigational lenacapavir,” the release reads.