FDA Approves Yeztugo: Twice-Yearly HIV Prevention Shot Marks Major AIDS Breakthrough. This new injectable medication, lenacapavir, offers a significant advance in HIV prevention, showing near-zero infection rates in clinical trials. While pricing is comparable to other similar drugs at $28,218 annually, its potential to help end the HIV epidemic is undeniable
FDA Approves Yeztugo: Twice-Yearly HIV Prevention Shot Marks Major Breakthrough
FDA-Approved HIV Prevention Shot, Yeztugo (lenacapavir), Launches in the US: Availability Details Pending
Gilead Science CEO Daniel O’Day said in a statement the approval could help make the goal of ending HIV “a reality,” saying the injectable “offers a very real opportunity to help end the HIV epidemic.”
Yeztugo has an annual list price of $28,218 before insurance, a figure similar to prices of other branded medications approved for the same use, according to CNBC.
Gilead’s stock spiked following the approval, though it quickly dropped back down to roughly flat on the day—in line with broader market movements.
The approval comes after two clinical Yeztugo trials showed the drug could nearly prevent all HIV infections, with zero infections among 2,134 participants in one trial and two infections among 2,179 participants in another trial.
Yeztugo is Gilead’s latest pre-exposure treatment for HIV prevention, as the pharma company has also produced daily oral pills (Truvada and Descovy) to reduce the risk of HIV infection.
Get Forbes Breaking News Text Alerts: We’re launching text message alerts so you’ll always know the biggest stories shaping the day’s headlines. Text “Alerts” to (201) 335-0739 or sign up here.
Gilead’s stock has nearly doubled in the past year, trading around $63 per share one year ago. The pharmaceutical company has benefited from strong earnings and sales of its HIV drugs , exceeding Wall Street expectations with a 6% year-over-year revenue increase reported in its final quarter of 2024.
1.2 million. That is the number of people in the U.S. estimated to have HIV in 2022, with around 31,800 people contracting the virus that year, according to the Centers for Disease Control and Prevention.
HIV, which stands for human immunodeficiency virus, targets the body’s immune system and can lead to AIDS (acquired immunodeficiency syndrome) without treatment. HIV has no cure, but advancements in treatments allow those with HIV to live long lives. Meanwhile, pre-exposure treatments made by companies like Gilead have proven effective in preventing transmission of the virus. However, staffing and funding cuts by President Donald Trump against the CDC have impacted HIV research and prevention efforts, NBC News reported, noting cuts have impacted surveillance of HIV among gay men, a demographic disproportionately affected by HIV.
Trump administration axes more than $125M in LGBTQ health funding, upending research field (NBC News)
Source: Original Article