EU regulator approves injectable HIV drug that experts say could help stop transmission
The European Medicines Agency has recommended authorizing a twice-yearly injectable drug aimed at preventing HIV, which scientists say could help end the virus' transmission.
In a statement on Friday, the EU drug regulator said its evaluations of lenacapavir, sold as Yeytuo in Europe by Gilead Sciences, showed the drug is "highly effective" and "considered to be of major public health interest." Once the regulator's guidance is accepted by the European Commission, the authorization is valid in all 27 EU member countries as well as Iceland, Norway and Liechtenstein.
Last year, studies suggested that lenacapavir, already used to treat people with HIV, was nearly 100% effective in stopping transmission in both women and men.
Winnie Byanyima, executive director of the U.N. AIDS agency, has said the drug "could change the trajectory of the HIV epidemic" if it is made available to everyone who needs it.
In June, the U.S. Food and Drug Administration authorized lenacapavir to prevent HIV. Earlier this month, the World Health Organization recommended countries offer the drug as an additional option to people at risk of the virus.
Condoms help guard against HIV infection if used properly. Other medication aimed at preventing HIV include daily pills that people can take and another injectable drug called cabotegravir, which is given every two months. Lenacapavir's six-month protection makes it the longest-lasting type, an option that could attract people wary of more visits to health clinics or stigma from taking daily pills.
Critics have raised concerns, however, that lenacapavir may not be made widely enough available to stop global outbreaks of HIV. Drugmaker Gilead has said it will allow cheap, generic versions to be sold in 120 poor countries with high HIV rates — mostly in Africa, Southeast Asia and the Caribbean.
But it has excluded nearly all of Latin America, where rates are far lower but increasing, sparking concern the world is missing a critical opportunity to stop the disease.
Last year, there were about 630,000 AIDS deaths worldwide and more than 40 million people are estimated to have HIV, according to UNAIDS.
UNAIDS chief Byanyima has previously suggested the U.S. President Donald Trump make a deal with Gilead to produce and license its "magical" prevention drug lenacapavir across the world to the millions of people who need it.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
L'Orient-Le Jour
28-07-2025
- L'Orient-Le Jour
EU proposes suspending funding for Israeli startups
The European Commission proposed on Monday to suspend funding for Israeli startups due to the dire humanitarian situation in Gaza. "Even though Israel has announced a daily humanitarian pause in the fighting in Gaza and has met some of its commitments (...), the situation remains serious," the European executive said in a statement. A report by the European Commission, presented to the 27 member states at the end of June, found that Israel was violating an article of the association agreement binding it to the EU, notably in terms of respecting human rights. The European executive has since been working on its response, debating several possible options: banning certain exports, revising its visa policy, and so on. The proposal presented Monday is among the more cautious options. It consists of partially suspending Israel's participation in the major Horizon Europe research program. Startups specifically targeted include those specializing in cybersecurity, drones, or artificial intelligence. The European executive describes this measure as "targeted" and "reversible." This proposal will be subject to approval by EU member states and will be discussed at a meeting on Tuesday. The 27 member states have been particularly divided on what stance to take towards Israel since the start of its devastating war in Gaza in October 2023. Several member states, including Germany, insist on Israel's right to defend itself, in accordance with international law, while others, such as Spain, condemn what they describe as "genocide" against Gaza's Palestinians. On Sunday, the World Health Organization (WHO) warned that malnutrition rates in the Gaza Strip had reached "alarming levels," with "a peak in deaths in July." According to the Health Ministry of the enclave, at least 147 Palestinians have been recorded as having died from famine and malnutrition, including 14 new cases in the past 24 hours. In total, at least 59,921 people have been killed by Israeli army attacks since the beginning of its offensive against the besieged Palestinian territory.
Nahar Net
25-07-2025
- Nahar Net
EU regulator approves injectable HIV drug that experts say could help stop transmission
by Naharnet Newsdesk 25 July 2025, 15:51 The European Medicines Agency has recommended authorizing a twice-yearly injectable drug aimed at preventing HIV, which scientists say could help end the virus' transmission. In a statement on Friday, the EU drug regulator said its evaluations of lenacapavir, sold as Yeytuo in Europe by Gilead Sciences, showed the drug is "highly effective" and "considered to be of major public health interest." Once the regulator's guidance is accepted by the European Commission, the authorization is valid in all 27 EU member countries as well as Iceland, Norway and Liechtenstein. Last year, studies suggested that lenacapavir, already used to treat people with HIV, was nearly 100% effective in stopping transmission in both women and men. Winnie Byanyima, executive director of the U.N. AIDS agency, has said the drug "could change the trajectory of the HIV epidemic" if it is made available to everyone who needs it. In June, the U.S. Food and Drug Administration authorized lenacapavir to prevent HIV. Earlier this month, the World Health Organization recommended countries offer the drug as an additional option to people at risk of the virus. Condoms help guard against HIV infection if used properly. Other medication aimed at preventing HIV include daily pills that people can take and another injectable drug called cabotegravir, which is given every two months. Lenacapavir's six-month protection makes it the longest-lasting type, an option that could attract people wary of more visits to health clinics or stigma from taking daily pills. Critics have raised concerns, however, that lenacapavir may not be made widely enough available to stop global outbreaks of HIV. Drugmaker Gilead has said it will allow cheap, generic versions to be sold in 120 poor countries with high HIV rates — mostly in Africa, Southeast Asia and the Caribbean. But it has excluded nearly all of Latin America, where rates are far lower but increasing, sparking concern the world is missing a critical opportunity to stop the disease. Last year, there were about 630,000 AIDS deaths worldwide and more than 40 million people are estimated to have HIV, according to UNAIDS. UNAIDS chief Byanyima has previously suggested the U.S. President Donald Trump make a deal with Gilead to produce and license its "magical" prevention drug lenacapavir across the world to the millions of people who need it.
MTV Lebanon
16-07-2025
- MTV Lebanon
US senators exempt HIV/Aids funding from planned spending cuts
Republicans in the US Senate have said they will spare the US-backed HIV/Aids programme Pepfar from cuts, amid a larger effort to reduce government spending. Senators said they would end a plan to cut $400m (£300m) from the President's Emergency Plan for Aids Relief programme, leaving total proposed cuts at $9bn. The proposition was made in a Senate amendment to a rescissions package - meaning a bill that allows lawmakers to cancel previous funding approved by Congress. The planned cancellations also include funds for international aid and public broadcasting. If the Pepfar amendment is approved, the bill will go back to the House of Representatives for another vote ahead of a Friday deadline. Multiple senators from both parties had expressed concern with cuts to Pepfar, which was launched under President George W Bush and has been credited with saving tens of millions of lives around the world, especially in Africa. The Republican-controlled Senate can only afford a few defectors, assuming all Democrats vote in opposition. John Thune, the Republican Senate majority leader, said there had been a "lot of interest" in keeping the Pepfar funding intact. Senator Susan Collins, a Republican from Maine, told reporters after a White House lunch on Tuesday that she was "very pleased" that the cuts would be removed. Prior to the amendment, Collins had been vocal against the bill. She has not said whether the changes are enough to secure her support. Office of Management and Budget (OMB) Director Russell Vought told reporters that the White House was on board with the Senate amendment, meaning that in its current form President Donald Trump would be willing to sign it. In his second presidency, Trump has turbo-charged an effort to reduce government spending. Most of the cuts in the rescission bill are aimed at clawing back money that was previously earmarked for the American government's main humanitarian assistance body, USAID, which recently announced its formal closure under Trump. Trump's moves have led to drastic reductions in HIV/Aids clinics in South Africa and other countries, precipitating a shortage of life-saving medicine and care. The about-turn was welcomed by Prof Helen Rees who specialises in HIV, vaccine-preventable diseases and sexual health at the University of the Witwatersrand in Johannesburg. "This is very good news," she told the BBC. "It's obviously not replacing the totality of what Pepfar was providing but nonetheless it indicates a softening of the views in the US and the importance to the members of the Senate of the Pepfar programme in terms of lives saved." She added that the sudden withdrawal of the funding was "a huge threat to the lives of many people, particularly in lower-income countries and particularly in Africa".
