Gilead's Long-Acting HIV Therapy Lenacapavir Approved in China with Twice-Yearly Dosing

Source: Medicines Outlook

Today (January 2),The official website of China's National Medical Products Administration (NMPA) has recently announced,Gilead SciencesNew Class 5.1 Drug Filed by Gilead SciencesLenapavir TabletsAndLenapevir InjectionMarketing application has been approved. Public information shows that Lenacapavir is an HIV-1 capsid inhibitor. The drug has been approved for marketing in the EU, the United States, and other places, forIn combination with other antiretroviral drugs for the treatment of adults with multidrug-resistant HIV infection. This long-acting HIV therapy was also selected by *Science* magazine as one of the highlights in its recent announcement for 2024.Breakthrough of the Year。

According to a previous press release from Gilead Sciences, lenacapavir will offer a new treatment option for HIV patients who do not respond effectively to existing therapies.Only twice a yearA brand new treatment regimen.Lenapevir is available in two formulations: 300mg tablets and 463.5mg/1.5mL injectable solution, whereTablets are approved for oral administration at the start of treatment, depending on the initial treatment option, and can be taken before or at the time of the first dose of long-acting lenapavir injection.. Lenapavir injection only requiresOnce every six months, subcutaneous injection.

AIDS was once considered a fatal disease with no cure. With the establishment of highly active antiretroviral therapy, commonly known as "cocktail therapy," AIDS has become a manageable chronic condition. HoweverPeople living with HIV still face unmet needs,Especially those HIV-infected individuals who have undergone extensive treatment with limited options, and due to drug resistance or difficulty in adhering to complex treatment regimens.Due to the large number of medications, high dosage, and frequent administration associated with antiretroviral therapy,MoxaPatients with AIDS often need to take medication for life.To achieve long-term viral suppression,Medication adherence becomes a major challenge for patients.

LenapevirIs aLong-acting HIV Capsid Inhibitor, unlike most antiviral drugs that only target one stage of viral replication,This product has a multi-stage mechanism of action, capable of blocking HIV at multiple stages of its life cycle.Including the inhibition of HIV-1 proviral DNA uptake, assembly, and release mediated by the viral capsid, as well as the formation of the viral capsid core,And there is no known cross-resistance to existing other drug classes.. This product provides a long-acting treatment option for multidrug-resistant HIV patients (for whom the virus no longer responds effectively to treatment).

August 2022,LenapevirThe drug was the first in the world to be approved in the EU for use in combination with other antiretroviral drugs to treat adult patients with multidrug-resistant HIV infection. In December of the same year, the drug was also approved in the United States.ApprovedThe above indications.

The approvals from the European Commission (EC) and the U.S. FDA were supported by data from a Phase 2/3 clinical trial named CAPELLA. The trial aimed to evaluate the treatment of multidrug-resistant HIV-1 infection in heavily treatment-experienced patients.LenapevirEfficacy of a combined optimized background regimen.The median number of prior antiretroviral drugs received by subjects in the CAPELLA study was 9.。In this patient population with a significant unmet medical need, randomized enrollment was usedLenapevirAt Week 52 after combining with an optimized background regimen,83% of the subjectsAchieved undetectable viral load (<50 copies/mL). In addition, the average CD4 count of participants increased by 83 cells/μL.。CAPELLAThe main results of the study have been published in The New England Journal of Medicine.

Although current therapies cannot completely cure HIV infection, they can significantly reduce the amount of virus in a patient's body, maintain immune function, and prevent the spread of the HIV virus. With antiviral therapy, AIDS patients are able to achieve a life expectancy comparable to that of the general population. This time,Lenapevir Approved in ChinaThe launch will provide Chinese patients with a brand-new HIV treatment option.

It is worth mentioning that, after the approval of the indication for long-acting treatment of HIV infection,LenapevirImportant progress has been made this year in clinical research on the prevention of HIV infection.July 2024,LenapevirA study named PURPOSE 1Interim Results of Phase 3 Clinical TrialPublished in The New England Journal of Medicine (NEJM) journal. According to the paper, the productShowed 100% effectiveness in HIV prevention among women, showing significant superiority compared to once-daily oral therapy and the background incidence rate of HIV.And according to the results of the second Phase 3 clinical trial, PURPOSE 2, published in November, participants receivingLenapevirIn the injected subjects,Up to 99.9% remained uninfected with HIV, and its effectiveness in preventing HIV infection is superior to the existing once-daily oral therapy.Currently, the FDA has grantedLenapevirBreakthrough Therapy Designation for HIV PrEP, a series of global regulatory submissions are expected to begin by the end of this year.

ReferenceData:

[1] Drug Approval Certificate Delivery Information on January 2, 2025. From https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20250102154109161.html

[2] Sunlenca® (Lenacapavir) Receives FDA Approval As A First-In-Class, Twice-Yearly Treatment Option For People Living With Multi-Drug Resistant HIV. Retrieved December 22, 2022 from https://investors.gilead.com/news/news-details/2022/Sunlenca-lenacapavir-Receives-FDA-Approval-as-a-First-in-Class-Twice-Yearly-Treatment-Option-for-People-Living-With-Multi-Drug-Resistant-HIV/default.aspx

[3] Sunlenca®, a first-in-class therapy that requires dosing only twice a year, receives FDA approval for the treatment of people with multidrug-resistant HIV. Retrieved Jan 3, 2023 from https://mp.weixin.qq.com/s/ijPIyYDVhh7dP-8xJr7TyA

(Source: Pharma Observer)

Editor: Guo Mingyu