The Ministery of Food and Drug Safety said on the 7th that it approved the orphan drug Sunlenca injection and Sunlenca tablets (ingredient lenacapavir) for treating human immunodeficiency virus (HIV-1) infection.
HIV is a virus that attacks the cells (CD4+ T) responsible for the body's immunity, weakening immune function. Without treatment, it can progress to acquired immunodeficiency syndrome (AIDS).
Sunlenca, developed by Gilead in the United States, was approved by the U.S. Food and Drug Administration (FDA) in 2022. Sunlenca works differently from existing treatments. It targets the capsid protein, which serves as the virus's "shell," blocking the entire process from the virus entering the cell to replication and spreading outside.
This drug is used for "multidrug-resistant" HIV patients who saw no effect even after using multiple treatments. It is significant in that it could be a new alternative for patients who had few treatment options.
The Ministery of Food and Drug Safety designated this drug for Global Innovative Products Fast Track (GIFT) review to shorten the review period. The program is designed to quickly introduce highly innovative medicines among treatments for life-threatening diseases.
An official at the Ministery of Food and Drug Safety said, "We expect it will offer a new treatment opportunity for patients who have not seen sufficient effects with existing therapies," adding, "We will continue to promptly supply treatments whose safety and efficacy have been confirmed."