LONDON – The European Medicines Agency has proposed the approval of a bi-annual injectable medication designed to prevent HIV, which researchers believe could be a significant step towards halting the spread of the virus.
The EU drug agency announced on Friday that its assessment of lenacapavir, branded as Yeytuo in Europe by Gilead Sciences, indicates the drug is “highly effective” and is deemed to be of substantial importance to public health. Following the acceptance of the regulator’s recommendation by the European Commission, the approval would be applicable across all 27 EU member states, as well as in Iceland, Norway, and Liechtenstein.
Research conducted last year revealed that lenacapavir, which is already in use for treating individuals with HIV, was almost completely effective in preventing the virus’s transmission in both men and women.
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.
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