Breaking News - FDA Approves Game-Changing Injectable HIV Drug Yeztugo with 96% Prevention Rate

Lenacapavir Game-Changing Injectable HIV Drug Yeztugo.(Gilead Sciences Inc.)

Breaking – The US FDA Approves Twice-Yearly Injectable Drug to Prevent HIV

The Food and Drug Administration has approved a breakthrough medication that reduces the risk of contracting HIV by 96 percent. Gilead's Yeztugo, with the generic name lenacapavir (LEN), has been approved for prevention after highly successful trials in September found that it nearly eliminated the spread of the virus among patients. The drug demonstrated a 96 percent relative risk reduction versus HIV. It had previously been approved for the treatment of multidrug-resistant HIV.

This milestone follows promising 2024 results from the PURPOSE 1 and PURPOSE 2 trials, which demonstrated the safety and efficacy of lenacapavir across diverse populations and settings. Administered just twice a year, lenacapavir offers sustained protection and adds to the growing range of HIV prevention options.

Meanwhile, the World Health Organization (WHO) has welcomed the approval by the United States Food and Drug Administration of injectable lenacapavir for HIV prevention. WHO currently recommends oral PrEP, the dapivirine vaginal ring, and long-acting injectable cabotegravir (CAB-LA) as options for HIV pre-exposure prophylaxis (PrEP). Lenacapavir’s discreet, long-acting formulation may help overcome key barriers such as daily pill burden, frequent clinic visits, and the stigma associated with HIV prevention.

“This regulatory milestone brings us one step closer to expanding access to an innovative HIV prevention option in lenacapavir,” said Dr. Meg Doherty, Director of WHO’s Global HIV, Hepatitis and STI Programmes. “WHO plays a key role in supporting countries through guideline development, prequalification, and regulatory processes. We are working with partners and national authorities to ensure lenacapavir reaches people who need it most – quickly, safely, and equitably.”

WHO guidelines for injectable lenacapavir will be released on 14 July 2025 during the International AIDS Conference in Kigali.

Advocates around the world have since called for stakeholders to work together to ensure access to this intervention for those who need it most.

“The approval of LEN is a much-needed boost for HIV prevention, given the strength of the science and the simultaneous disruption in HIV programs globally,” said Mitchell Warren, Executive Director of AVAC. “But US FDA approval is just one in a series of steps needed to ensure that injectable LEN can help reduce the 1.3 million new HIV infections that occur each year. Scientific progress only matters if innovation actually reaches people. LEN for PrEP is poised to re-shape the HIV response, but only if today’s approval is accompanied by bold, strategic, effective, and equitable rollout that reaches the populations that need access. Otherwise, the world risks squandering this PrEP opportunity, as it has with other PrEP options too often over the past 12 years.”

In December, PEPFAR and the Global Fund announced a coordinated ambition to reach two million people within three years of product launch. This commitment signals an unprecedented opportunity to make PrEP access a reality. However, translating this ambition into impact—especially now amid the current political environment—is not without considerable challenges.

FDA approval also paves the way for WHO prequalification, which can accelerate national regulatory approvals following endorsement by a stringent regulatory authority (SRA) and procurement by donor agencies like the Global Fund. In parallel, WHO is working with the European Medicines Agency (EMA) to support the Medicines 4 All (M4All) mechanism, which facilitates regulatory pathways in countries adopting lenacapavir.

Source: Online News