FDA approves first twice-yearly HIV shot — Yeztugo now available in the U.S.
American company Gilead has received FDA approval for Yeztugo — the world’s first injection that protects against HIV for six months. Clinical trials showed an efficacy rate above 99.9%.
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A breakthrough drug for HIV prevention — Yeztugo by Gilead Sciences — has been approved in the United States.
This is the first injectable PrEP (pre-exposure prophylaxis) medication in the U.S. and globally that needs to be administered only twice a year.
The FDA (U.S. Food and Drug Administration) approved it on June 18 based on the results of two large-scale studies — PURPOSE 1 and PURPOSE 2.
More than 4,000 people participated in the trials. Among those who received Yeztugo shots every six months, HIV infections were almost nonexistent — with efficacy exceeding 99.9%.
Participants included women from African countries, as well as men and transgender individuals from various regions around the world.
According to Gilead CEO Daniel O’Day, the approval of Yeztugo could be a game-changer in the fight against the epidemic. “Many people don’t take daily pills, and a shot every six months can overcome that barrier,” he said.
The drug could also be particularly helpful for those facing stigma or with limited access to preventive care.
Yeztugo is lenacapavir, a capsid inhibitor that targets multiple stages of the virus’s life cycle.
Gilead is now launching a support program for uninsured individuals and is preparing approval applications in Europe, Canada, Brazil, and other countries.
Earlier, it was reported that at the World IDF Congress in Bangkok, experts officially recognized a new type of diabetes linked to malnutrition and announced the start of global protocol development for its study and treatment — a move that could significantly impact the global strategy against the disease.
It was also revealed that the American company Eli Lilly successfully completed trials of the first GLP-1-based tablet therapy, which simultaneously lowers blood sugar and aids in weight loss for patients with type 2 diabetes.