FDA Approves Medicine Reducing Risk Of Acquiring AIDS By Almost 100 Pct
(MENAFN- Kuwait News Agency (KUNA))
WASHINGTON, June 19 (KUNA) -- The US Food and Drug Administration (FDA) has approved a medicine that would reduce the risk of acquiring HIV in adults and adolescents by 99.9 percent.
Gilead Sciences, which developed the drug, announced that FDA approved Yeztugo (lenacapavir), an injectable HIV-1 capsid inhibitor as pre-exposure prophylaxis (PrEP) to reduce risk of sexually acquired HIV in adults and adolescents weighing at least 35kg, making it the first and only twice-yearly option available in the US for people who need or want PrEP.
Data show that 99.9 percent of participants who received Yeztugo in the Phase III Purpose One and Purpose Two trials remained HIV negative, it said.
"This is a historic day in the decades-long fight against HIV. Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic," Daniel O'Day, Chairman and Chief Executive Officer of Gilead Sciences, said in a statement.
"This is a medicine that only needs to be given twice a year and has shown remarkable outcomes in clinical studies, which means it could transform HIV prevention," he added.
Approval was Based on Phase III Purpose one and purpose two Data that Showed 99.9 percent of Participants Remained HIV Negative on Twice-Yearly Injectable Yeztugo.
The company said Yeztugo, nearly 20 Years in the making, represented a Major Breakthrough in the Fight Against HIV.
Gilead was founded in 1987 to bring new hope in the face of devastating diseases.
The World Health Organization (WHO) said a virus attacks white cells thus making the immune system vulnerable and caused Acquired immunodeficiency syndrome (AIDS). (end)
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Gilead Sciences, which developed the drug, announced that FDA approved Yeztugo (lenacapavir), an injectable HIV-1 capsid inhibitor as pre-exposure prophylaxis (PrEP) to reduce risk of sexually acquired HIV in adults and adolescents weighing at least 35kg, making it the first and only twice-yearly option available in the US for people who need or want PrEP.
Data show that 99.9 percent of participants who received Yeztugo in the Phase III Purpose One and Purpose Two trials remained HIV negative, it said.
"This is a historic day in the decades-long fight against HIV. Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic," Daniel O'Day, Chairman and Chief Executive Officer of Gilead Sciences, said in a statement.
"This is a medicine that only needs to be given twice a year and has shown remarkable outcomes in clinical studies, which means it could transform HIV prevention," he added.
Approval was Based on Phase III Purpose one and purpose two Data that Showed 99.9 percent of Participants Remained HIV Negative on Twice-Yearly Injectable Yeztugo.
The company said Yeztugo, nearly 20 Years in the making, represented a Major Breakthrough in the Fight Against HIV.
Gilead was founded in 1987 to bring new hope in the face of devastating diseases.
The World Health Organization (WHO) said a virus attacks white cells thus making the immune system vulnerable and caused Acquired immunodeficiency syndrome (AIDS). (end)
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