Aikening ® (albuvirtide) Granted Marketing Authorisation by the Ministry of Health in the Republic of Kazakhstan for the Treatment of HIV-1

  • 2023-06-09  13:38:09

Frontier Biotechnologies announced it obtained approval for Aikening® (albuvirtide for injection), the first long-acting fusion inhibitor treatment for HIV, from the Ministry of Health in the Republic of Kazakhstan.

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 35,000 people are living with HIV in Kazakhstan, and the prevalence rate is 0.3%. And 64% of PLHIV are receiving antiretroviral treatment (ART), only 55% of PLHIV have suppressed viral loads, reported in 2021. Market access in Kazakhstan requires listing into WHO Essential Medicines List.

About Aikening®

Aikening® is a new and innovative pharmaceutical entity discovered, developed and manufactured by Frontier Biotechnologies.

In May 2018, Aikening® received drug registration approval from the National Medical Products Administration in China. In October 2018, Aikening® was included as one of the major antiretroviral (ART) drugs 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 listed in China’s National List of Essential Medical Insurance, Industrial Injury Insurance and Maternity Insurance Drugs (2020).

Aikening®, in combination with other antiretroviral agent(s) for treatment of HIV-1, is effective against both major and drug-resistant viral strains. Owing to its new mechanism of action, fast onset of action, high barrier to resistance and a well-tolerated safety profile, Aikening® is widely accepted in the real-world setting as an ART for patients with high unmet needs, such as HIV hospitalization and critically-ill patients, and those with co-morbidities such as liver impairment, kidney disease and multiple drug-resistance.

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