FDA agrees to “collapse” to prevent HIV

The Food and Drug Administration has just agreed to the anti -HIV drug, which is widely considered a penetration.

On Wednesday afternoon, the Food and Drug Administration (FDA) agreed to Gilead Sciences’ Lenacapavir as a more convenient form of prevention before exposure (Prep). In clinical trials, it was found that the drug is very effective in preventing HIV infection when taking only twice a year. Meanwhile, Gilead defenders and US officials urge to ensure the audience on a large scale.

“Prep is one of the most indispensable tools to finish HIV. The presence of a snapshot option, instead of relying on daily birth control pills, will make the long -term commitment to prepare much easier for many,” said Kevin Robert Frost, CEO of AMFAR, the Foundation in a statement submitted to Gizmodo. “But this wonderful medicine will not be effective, but it can be reached at reasonable prices.”

The Food and Drug Administration (FDA) first approved Lenacapavir in 2022 as an antiviral treatment for HIV, which was marketed under the name Sunlenca. It was the first approved transaction for a new HIV – medications that directly target capside, or chance, for the virus. This alone made LenacAPavir vital progress, as it can treat infections that have become resistant to other drugs. But the greatest potential of the drug may come from its vaccine -like ability to prevent the virus from obtaining a foothold in the first place.

A year ago, Jaadad Absolute The results of the third stage experience, which tested the preparatory injection twice from Lenacapavir in the women of Cisgender. The drug outperforms daily preparatory options with a 100 % preventive rate. A subsequent trial as well Show 99.9 % prevention rate among the men of Cisgender, men and women of transgender, and non -bilateral individuals between the sexes. The success of the drug was so impressive Bee It is also the penetration of the search for this year. Gilead is also now study If a single annual dose can be effective.

Regardless of the arrival of Lenacapavir, its cost may constitute a problem – especially to give Gilead’s reputation. The company has been appointed long ago High list prices are often increasing For her previous preparatory drugs and her and her Resist US and others attempts to reduce these prices (To this dayThe offer can cost a month of Truvada up to $ 2000 without insurance). Gilead has also been accused of trying to delay the development of the cheapest limestone, although they are now. In 2023, the company settled a Collective lawsuit On these allegations.

NBC News I mentioned Wednesday that the preparatory version of the LenacAPAVIR, which was sold under the name of the YEZTOGO brand, will have a list of $ 14,109 per injections, or $ 2,352 per month. In announcing the approval of the FDA, Gilead I mentioned It is “working closely with insurance companies, healthcare systems and other motivators to ensure extensive insurance coverage.” You will also create programs aimed at reducing the costs of Yeztugo outside the pocket up to $ 0 for some qualified people with or without insurance.

Time will have to know if these assurances will be sufficient to make the medicine well -affordable and accessible to Americans and in the end every person in the world.

“AMFAR calls Gilead Sciences and the American government to do everything they can to make sure that many people want Lenacapavir they can get.”