Gilead Sciences Lenacapavir MAA gets EMA validation to treat HIV-1

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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