South Korea's Ministry of Food and Drug Safety (MFDS) has approved a new treatment option for HIV patients who do not respond to existing therapies.
The MFDS said Monday that it approved the imported orphan drugs Sunlenca Injection and Sunlenca Tablets (active ingredient: lenacapavir) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
Lenacapavir is a first-in-class treatment that targets the capsid protein of HIV-1. It works by blocking the process through which the virus enters the cell nucleus, while simultaneously inhibiting viral assembly and release and inducing abnormal capsid formation to prevent replication.
The approved indication covers adult patients with multidrug-resistant HIV-1 infection who are difficult to treat with existing antiretroviral therapies. The drug is intended for patients who have failed prior treatments and have limited alternative treatment options.
HIV infection is a disease that, without proper treatment, can severely compromise immune function and progress to acquired immunodeficiency syndrome (AIDS). For multidrug-resistant patients in particular, treatment options have been limited, and the need to introduce therapeutics with novel mechanisms of action has been consistently raised.
"This approval is expected to provide a new treatment opportunity that addresses unmet medical needs not fulfilled by existing therapies," the MFDS said.