Twice-yearly injectable HIV drug Sunlenca nears approval in Korea

MFDS completes safety and efficacy review…biannual dosing improves convenience in administration

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Gilead Sciences’ multidrug-resistant HIV treatment Sunlenca (lenacapavir sodium) is reportedly nearing marketing approval in Korea.

The drug was designated in March last year for the MFDS GIFT (Global Innovative product on Fast Track) program, and it has recently been reported that the safety and efficacy review has been completed.

According to industry sources on the 19th, the MFDS has completed its safety and efficacy assessment of Sunlenca. Once a product passes this stage, only the final approval process typically remains. In addition, products that have undergone safety and efficacy reviews can apply for reimbursement to the Health Insurance Review and Assessment Service (HIRA) under the approval–reimbursement assessment linkage system.

Observers predict that if Sunlenca has received a positive determination in the safety and efficacy review, it is highly likely to receive marketing authorization approval in the near future.

Sunlenca is a first-in-class capsid inhibitor that targets multiple stages of the HIV replication cycle. It is primarily aimed at patients with multidrug-resistant HIV who have developed resistance to existing treatments and have no further treatment options.

It inhibits HIV-1 at multiple points throughout the viral lifecycle, including by interfering with the capsid-mediated nuclear entry of the pre-integration complex and impairing virion production and proper capsid core formation.

A key feature of the drug is its twice-yearly injectable dosing, offering improved convenience.

This is because it is a “long-acting” formulation that requires only a single injection every 6 months (26 weeks) during the maintenance phase, after an initial phase combined with oral therapy. As a result, it is widely recognized for significantly reducing the psychological burden and inconvenience previously experienced by patients who had to take medication daily.

An industry official stated, “Sunlenca is of great clinical significance in that it provides strong viral suppression through a completely new mechanism for these patients. In particular, the fact that it is a long-acting injectable administered once every six months can maximize patient adherence.”

Sunlenca has already been approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and is currently in use. Recently, it has also demonstrated exceptional efficacy as a pre-exposure prophylaxis (PrEP), drawing attention as a potential game-changer, set to reshape the HIV treatment market.

The FDA approved Sunlenca in December 2022, following fast-track, breakthrough therapy designation (BTD), and priority review (PR) designations. The EMA approved it earlier in August 2022, and Japan’s PMDA approved it through priority review in August 2023.

In Korea, it was designated an orphan drug in December 2024, and on March 4 last year, it was designated as GIFT product No. 46, reflecting the lack of existing treatment options.

The indication submitted for its use in Korea is as combination therapy with other antiretrovirals for the treatment of HIV-1 infection in hin adults with multidrug-resistant HIV-1 infection who have a history of treatment failure with current antiretroviral therapy due to resistance, intolerance, or safety issues.