Latest news with #Yeytuo
Al-Ahram Weekly
4 days ago
- Health
- Al-Ahram Weekly
EU regulator green lights an injectable HIV drug that could help stop transmission - Health - Life & Style
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 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 that 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. Follow us on: Facebook Instagram Whatsapp Short link:
New Indian Express
5 days ago
- Health
- New Indian Express
HIV prevention: Gilead's vaccine breakthrough nears EU approval
CHENNAI: Gilead Sciences has achieved another milestone in its efforts to bring in a preventive drug to curb the still rapidly spreading HIV epidemic, in the world with the European Medicines Agency's (EMA) advisory committee issuing a positive opinion for its twice-yearly injectable, lenacapavir. EMA the decision on Thursday (July 24) clears the way for approval by the European Commission later this year, following similar regulatory clearance in the United States in June 2025. Lenacapavir, a HIV pre-exposure prophylaxis (PrEP), is to be marketed in Europe under the brand name Yeytuo, is a long-acting injectable designed to prevent HIV infection with just two subcutaneous doses annually, following an initial oral lead-in. This innovative therapy is part of a new class of HIV-1 capsid inhibitors that disrupt multiple stages of the viral replication cycle. It represents the first and only twice-yearly PrEP option for individuals at risk of HIV, offering a significant alternative to the currently available daily oral pills like Truvada (TDF/FTC). Clinical trials have demonstrated strong efficacy. In the PURPOSE 1 trial, conducted among over 5,000 cisgender women and adolescent girls in South Africa and Uganda, lenacapavir achieved 100% efficacy—zero new HIV infections were reported in the treatment group. A second trial, PURPOSE 2, involving a broader group of cisgender men, transgender, and non-binary adults, showed a 96% reduction in HIV risk compared to those on daily PrEP. These results prompted early unblinding of both trials due to overwhelming benefit. Participants also reported high satisfaction with the twice-yearly regimen, citing ease of adherence, reduced stigma, and fewer missed doses compared to daily pills. Gilead's chief medical officer, Dr. Dietmar Berger, was on Friday quoted in reports saying that lenacapavir 'has the potential to become a critical tool for public health,' especially for individuals who face barriers to consistent healthcare access. The product is expected to play a vital role in addressing rising HIV infections in Europe, where more than 24,700 new diagnoses were reported in 2023—an 11.8% increase from the previous year across the EU, Iceland, Liechtenstein, and Norway. Beyond Europe, Gilead is pursuing a global access strategy for lenacapavir. The company has licensed the drug for generic production in 120 low-and lower-middle-income countries and is working toward WHO prequalification and inclusion in international HIV prevention guidelines. It is also eligible for EU-M4all procedures, which would streamline regulatory pathways for resource-limited settings.
NDTV
6 days ago
- Health
- NDTV
EU Regulator Approves Twice-Yearly Injectable Drug For HIV Prevention
LONDON: 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 US 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.
6 days ago
- Health
EU regulator green lights an injectable HIV drug that could help stop transmission
LONDON -- 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 that 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. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
Hamilton Spectator
6 days ago
- Health
- Hamilton Spectator
EU regulator green lights an injectable HIV drug that could help stop transmission
LONDON (AP) — 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 that 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. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
