Twice-yearly 'lenacapavir' for HIV expected to land in KOR

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)

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 countries like the United States and Europe in 2022 and is currently being prescribed.

 

Current HIV treatment is maintained through daily oral administration of antiretroviral drugs.

 

However, with the development of long-acting formulations, the administration frequency is advancing to once every two months or once every six months.

 

Lenacapavir is also garnering more attention for its potential in HIV 'prevention,' not just treatment.

 

In June, this drug received approval in the U.S., and more recently in Europe, for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at-risk adults and adolescents weighing at least 35 kg.

 

The product name for lenacapavir used in prevention is 'Yeytuo.' The efficacy of lenacapavir for prevention was proven through the Phase 3 PURPOSE 1 and PURPOSE 2 studies.

 

The PURPOSE 2 study results showed that lenacapavir reduced HIV infection by 96% compared to the background HIV incidence (bHIV).

 

In the study, 2 cases occurred among 2,180 participants, meaning that 99.9% of the lenacapavir arm did not contract HIV.

 

Last year, Gilead also prematurely unblinded its PURPOSE 1 trial, which evaluated lenacapavir as PrEP in cisgender women in Sub-Saharan Africa, after it met its primary efficacy endpoint.

 

Meanwhile, the international science journal and news Science selected lenacapavir as its 'Science Innovation of the Year' last year based on these research results.