FDA approves revolutionary HIV medication: only two syringes annually!

FDA approves revolutionary HIV medication: only two syringes annually!
Vienna, Österreich - On June 19, 2025, the US drug authority FDA approved the Gilead medication for the prevention of HIV. According to clinical studies, this new means offers impressive protection of 99.9% against HIV infection. It is particularly noteworthy that it only requires two injections per year, often require daily medication during current prevention methods. Gilead Managing Director Daniel O’Day described this day as historically in the fight against HIV.
The approval follows a comprehensive clinical study in which over 4,000 participants were involved. Of these, only two people fell ill, which underlines the effectiveness and safety of the drug. The most common side effects include reactions at the injection site, headache and nausea. The cost of Lenacapavir is $ 28,000 (approx. 24,000 euros) per person and year, while experts appreciate the production costs at around $ 40.
costs and availability
In order to ensure access to Lenacapavir in low -income countries, Gilead has already completed license contracts with six generic manufacturers in October 2024. These are intended to produce and sell the drug in these regions. Meanwhile, critics have pointed out that inexpensive versions are already available in many countries, which raises questions about the prices of Gilead.
At the same time, however, the FDA also put five clinical studies for Gilead's investigative weekly HIV combination medication on hold after a safety signal was found. This combination therapy, which Lenacapavir contains, is approved as Sunleca for the semi -annual treatment of people with multi -resistant HIV and is currently being examined for the prevention of HIV.The future of HIV therapies
Gilead plans to integrate combination therapy with Lenacapavir and one of the injectable medication (GS-1219 or GS-3242) by the end of the year. The phase II/III studies led to the approval of Lenacapavir, including Purpose 1 and Purpose 2, show impressive results in HIV prevention. In particular, the Purpose 1 study reported 100%effectiveness in cisender women, while Purpose 2 showed a 96%reduction in HIV incidence in a more diverse population.
Overall, Gilead emphasizes the importance of prevention in the fight against HIV epidemic. Accordingly, the company has undertaken to offer or wish everyone who needs HIV prevention. This development is part of a more comprehensive commitment of Gilead to promote further innovations and to improve access to long -effective prevention methods worldwide in order to end the epidemic for all people.
Vienna reports that Gileads decisions and development plans play a key role in current progress in the area of HIV prevention. Gilead himself provides information about the importance of cooperation with partners to improve access to these vital therapy options, as shown on your Website Despite the challenges and the temporary interruption of studies, the company remains optimistic about the future of its products, as well as reported.
Details | |
---|---|
Ort | Vienna, Österreich |
Quellen |