China-based Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) has announced that its Category 1 compound preparation ACC007 (ainuovirine, lamivudine, tenofovir disoproxil) has been approved by the National Medical Products Administration (NMPA) for the treatment of newly treated adult patients with HIV-1 infection. This approval marks a significant step forward in the development and availability of innovative HIV treatments.
Clinical Development and Approval
ACC007 was approved for a Phase III clinical study in treatment-naïve HIV-1 infected patients in July 2020 and was accepted for marketing review by the NMPA in May 2021. The Phase III study, which compared ACC007 with Genvoya, completed enrollment of previously treated HIV-infected patients. The drug, taken orally once per day, offers a convenient dosing regimen that enhances patient compliance and reduces the risk of drug resistance.
Therapeutic Profile
ACC007 is a fixed-dose combination of antiretroviral drugs designed to provide a comprehensive treatment option for HIV-1 infection. The combination of ainuovirine, lamivudine, and tenofovir disoproxil allows for a less burdensome medication regimen, improving patient adherence and overall treatment outcomes. The approval of ACC007 underscores the ongoing efforts to address significant unmet needs in HIV treatment.
Future Outlook
The approval of ACC007 by the NMPA highlights Jiangsu Aidea Pharmaceutical’s commitment to advancing innovative treatments for HIV-1 infection. With its demonstrated efficacy and safety profile, ACC007 is poised to make a meaningful impact on patient outcomes. Aidea’s ongoing efforts in clinical development highlight its dedication to improving treatment options and addressing significant unmet needs in the field of HIV/AIDS.-Fineline Info & Tech