Gilead's twice-yearly shot fewer HIV infections by 96%, the corporate announced in a second major study on Thursday.
The positive results of the Phase 3 study on Lenacapavir create the conditions for a probable approval of the drug for HIV prevention by the US health authority FDA.
“Now that we have a comprehensive dataset from multiple study populations, Gilead will urgently work with regulators, governments, public health and community partners to ensure that, if approved, we can supply lenacapavir twice-yearly for PrEP to everyone who wants or needs PrEP globally,” Gilead CEO Daniel O'Day said in an announcement.
PrEP, or pre-exposure prophylaxis, is a drugs used to forestall HIV infection, in keeping with the Centers for Disease Control and Prevention.
Gilead shares rose greater than 1 percent on Thursday.
The company said 99.9% of participants who received lenacapavir didn’t turn out to be infected with HIV. There were two cases amongst 2,180 people. The study included cisgender men, transgender men, transgender women, and gender nonbinary individuals who have sex with partners assigned male at birth.
There were nine cases of HIV in a bunch of greater than 1,000 individuals who received Truvada, Gilead's older each day pill for prevention and treatment. The company said lenacapavir was 89 percent more practical than Truvada within the study.
Lenacapavir and Truvada were also “generally well tolerated” by patients, in keeping with Gilead, and there have been no recent safety concerns. The drugmaker plans to present detailed data at an upcoming medical conference.
Gilead also said in June that lenacapavir was 100% effective in stopping HIV in one other late-stage study of cisgender women. As of an interim evaluation in September 2023, not one of the roughly 2,000 women within the study who received the vaccine had turn out to be infected with HIV.
In a research note Thursday, Jefferies analyst Michael Yee said overall the information on lenacapavir were “solid and consistent across both studies and populations.”
The test results should result in FDA approval and market launch by 2025, Yee said.
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