Gilead Sciences Lenacapavir MAA gets EMA validation to treat HIV-1
Foster City: Gilead Sciences, Inc. has recently announced that the company's Marketing Authorization Application (MAA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, has been fully validated and is now under evaluation with the European Medicines Agency (EMA).
The proposed indication is for the treatment of HIV-1 infection, in combination with other antiretroviral(s), in adults with multidrug resistant HIV-1 infection who are currently on a failing antiretroviral treatment regimen due to resistance, intolerance or safety considerations.
The application will be reviewed by the EMA's Committee for Medicinal Products for Human Use (CHMP) under the centralized licensing procedure for all 27 Member States of the European Union, as well as Norway, Iceland and Liechtenstein.
"Lenacapavir is a breakthrough innovation that has the potential to be transformative for people with multi-drug resistant HIV, who have very limited treatment options," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "The MAA validation is a step forward in our commitment to a patient-centered approach to helping all individuals living with HIV achieve and sustain viral load suppression, irrespective of their prior treatment history."
The MAA is supported by data from the ongoing CAPELLA study, which achieved its primary endpoint by demonstrating that a significantly higher proportion of participants randomly allocated to receive oral lenacapavir in combination with an optimized background regimen (n=24) achieved a clinically meaningful viral load reduction of at least 0.5 log10 copies/mL from baseline compared with those randomly allocated to receive placebo (n=12) during the 14-day functional monotherapy period (88% vs. 17%, p<0.0001).
Lenacapavir was generally well-tolerated, with no serious adverse events related to study drug and no study drug discontinuations through the 14-day period, including no discontinuations due to adverse events. These data were previously presented at the virtual 28th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2021). 26-week data from the CAPELLA study were presented at the 11th International AIDS Society (IAS) Conference on HIV Science. Additional data from the CAPELLA study will be presented at a future scientific conference.
In June 2021, Gilead submitted a New Drug Application (NDA) for lenacapavir seeking U.S. Food & Drug Administration (FDA) approval for the treatment of HIV-1 infection in heavily treatment-experienced people with multi-drug resistant HIV-1 infection in combination with other antiretrovirals.
In May 2019, the FDA granted Breakthrough Therapy Designation for the development of lenacapavir for the treatment of HIV-1 infection in heavily treatment-experienced patients with multi-drug resistance in combination with other antiretroviral drugs.
Lenacapavir is an investigational compound and is not approved by any regulatory authority for any use; its safety and efficacy are not established. There is no cure for HIV or AIDS.
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