Frontier Biotechnologies announced it obtained approval for Aikening® (albuvirtide for injection), the first long-acting fusion inhibitor treatment for HIV, from the National Pharmaceutical Regulatory Agency of Malaysia.
Aikening® is indicated to be used in combination with other antiretroviral agent(s) for treatment of HIV-1 infection in people living with HIV (PLHIV), who are experiencing HIV-1 replication, despite ongoing antiretroviral therapy. It is administered by intravenous infusion at a dose of 320 mg once a day on Day 1, 2, 3, and 8, and thereafter once a week.
An estimated 82,000 people are living with HIV in Malaysia, and the prevalence rate is 0.3%. Just 55% of PLHIV are receiving antiretroviral treatment (ART) and 1600 deaths due to AIDS was reported in 20211. There is still room to increase access of ART to PLHIV in Malaysia.
About Aikening®
Aikening® is Frontier Biotechnologies' original new pharmaceutical product with independent intellectual property rights in the world's major markets.
In May 2018, Aikening® received a new drug certificate from the State Drug Administration in China. In October 2018, Aikening® was included as one of the major antiretroviral drugs available in the Chinese guidelines for diagnosis and treatment of HIV/AIDS (2018) issued by the Chinese Medical Association's Infectious Diseases Unit and the China Center for Disease Control and Prevention. In December 2020, Aikening® was enlisted as an exclusive patented product in the National List of Essential Medical Insurance, Industrial Injury Insurance and Maternity Insurance Drugs (2020).
Aikening® in combination with other antiretroviral treatment is effective for both major and drug-resistant viral strains. In a real world setting, Aikening® was widely accepted as one of the ARTs for patients with high unmet needs such as HIV hospitalization and critically-ill patients, liver and kidney dysfunctional patients and multiple drug-resistant patients due to the new mode of administration (once-weekly injection), lower pill burden, fast onset of action, high resistance barrier and well tolerated safety profile.
Reference: 1AIDS info, Global data on HIV epidemiology and response; https://aidsinfo.unaids.org/ Accessed on 26 September 2022