Approval granted in the USA for new HIV prevention medication
Exciting Stride in HIV Prevention!
🔔 Boom! A groundbreaking HIV prevention medication, Lenacapavir, has been given the green light in the US! 💉🎉
Get this—on a historic Wednesday, the US Food and Drug Administration (FDA) gave a stamp of approval to Lenacapavir, produced by Gilead Sciences. The drug demonstrated a staggering 99.9% effectiveness in warding off HIV infection in clinical trials. That's right, y'all! It's almost like a freakin' vaccine! 💉🌟
The exciting twist? This new wonder drug calls for merely two injections per year. If you've been keeping up with HIV meds, you know that's a massive deviation from the daily drudgery we've been subjected to. Gilead CEO Daniel O'Day proclaimed, "This marks a watershed moment in the multi-decade crusade against HIV." 🌟💪
Now, the studies featuring over 4,000 participants weren't exactly a walk in the park, but the side effects were minimal, consisting of injection site reactions, headaches, and a smidge of nausea. However, the wallet-crushing price tag of $28,000 (roughly €24,000) per person per year as a preventive measure might give you a case of the shakes. experts mutter that the manufacturing costs should be around $40. 💸😲
Gilead has struck licensing deals with six generic manufacturers to churn out Lenacapavir for low-income nations in October 2024. But here's the catch: millions of HIV-infected individuals reside in places where an affordable Lenacapavir version remains an elusive fantasy. 🌍💔
Source: ntv.de, AFP
🔍 Additional Insights:
- Lenacapavir, a long-acting injectable medication, was initially approved in 2022 to treat multi-drug-resistant HIV, and is in the process of gaining approval from the European Medicines Agency, South African Health Products Regulatory Authority, and Brazil’s ANVISA for broader global availability. 🌐
- Experts estimate the cost of producing Lenacapavir generically could be as low as $35-$46 per person-year, dropping to around $25 per person-year with high demand. UNAIDS has urged Gilead to lower the price and ensure affordable access in low- and middle-income countries. 💸🌎
- As of June 2025, Gilead has stated its ambition to implement access plans for Lenacapavir in low- and middle-income countries, but specific launch dates in these regions remain undisclosed. 🕰️🌍
- Remarkably, Lenacapavir, the newly approved HIV prevention drug, also exhibits a promising potential for treating multi-drug-resistant HIV, as it's currently under review by various global regulatory bodies.
- Beyond HIV prevention, Lenacapavir's long-term implications extend to the field of science, with experts suggesting its production cost could plummet when produced generically, aiding in the management of chronic diseases such as HIV.
- The implementation of mental health therapies and treatments, fitness, exercise, nutrition, and overall health-and-wellness regimens should also be considered in the context of the long-term effects of HIV, given the positive outlook associated with HIV prevention medications like Lenacapavir.
- In light of cost concerns, relevant advocacy organizations have urged Lenacapavir's producer, Gilead Sciences, to reconsider the drug's price for broader accessibility, especially in low-income and middle-income countries.
- The space of community and employment policies should assess the potential socio-economic impacts of more accessible HIV prevention and treatment options like Lenacapavir, ensuring equitable access to healthcare services for all individuals affected by chronic diseases like HIV.
