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  • Twice-yearly 'lenacapavir' for HIV expected to land in KOR
  • by Eo, Yun-Ho | translator Hong, Ji Yeon | Sep 25, 2025 06:12am
The Ministry of Food and Drug Safety (MFDS) is currently reviewing the approval¡¦its initial indication was for 'treatment'
Received approval in overseas countries, such as the United States and Europe, for pre-exposure prophylaxis (PrEP)
 ¡ã Product photo of lenacapavir
'Lenacapavir,' a HIV prevention drug taken twice a year, is expected to be marketed in Korea.

According to industry sources, the Ministry of Food and Drug Safety (MFDS) is currently reviewing the approval of lenacapavir from Gilead Sciences Korea. The drug was designated as an orphan drug in January.

Its specific indication is "a combination therapy with other antiretroviral agents for the treatment of multidrug-resistant HIV-1 infection in adults who are not being treated with their current antiretroviral therapy."

This drug, marketed overseas under the brand name Sunlenca, is the first long-acting HIV-1 capsid inhibitor and is administered as a subcutaneous injection every six months. It was approved in
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