US approves generic version of world’s only twice-a-year HIV prevention shot
By: Nana Karikari, Senior Global Affairs Correspondent The United States Food and Drug Administration has granted authorization for a generic variant of the world’s sole bi-annual HIV prevention injection. This regulatory action represents a major breakthrough toward delivering the drug rapidly and affordably to 120 low- and middle-income nations. The announcement was delivered on Monday […]
The US Food and Drug Administration has authorized a generic version of the world's only twice-annual HIV prevention injection, lenacapavir. This breakthrough aims to swiftly and affordably deliver the drug to 120 low- and middle-income countries. The injectable medication, costing $40 per patient annually, provides greater convenience than daily oral pills while showing nearly complete prevention of new HIV infections among high-risk individuals.
Global health leaders believe this will significantly reduce HIV transmission rates, AIDS diagnoses, and mortality. Currently, 41 million people worldwide live with HIV, and 570,000 die from HIV-related causes annually. The generic version will be distributed outside the US, where the brand-name Yeztugo, produced by Gilead Sciences, remains under patent with a hefty price tag of $28,218 per year.
Six generic manufacturers secured royalty-free licensing agreements with Gilead to produce and distribute lenacapavir in sub-Saharan Africa, Asia, and Latin America. While the regulatory approval is a major milestone, securing funding for widespread distribution and reaching millions of people in need remains the next critical step.
Written by urgent.news from GBC Ghana's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
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