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Twice-Yearly Shot Achieves Near-Perfect Success in HIV Prevention Trials, Signaling End of Daily Pill Regimen

The U.S. Food and Drug Administration has granted tentative approval to Dr. Reddy's Laboratories for a low-cost generic version of the HIV prevention drug lenacapavir. The milestone paves the way for a $40-a-year regimen in 120 low- and middle-income countries.

Factlen Newsroom· Updated

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Illustration: The FDA's tentative approval clears the way for a generic twice-yearly HIV prevention injection to reach 120 developing nations.From: FDA Approves First Generic Twice-Yearly HIV Prevention Shot for Developing Nations

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Key numbers

100%
Efficacy in PURPOSE 1 trial (cisgender women)
99.9%
Efficacy in PURPOSE 2 trial (diverse global cohort)
2
Injections required per year

From: Twice-Yearly Shot Achieves Near-Perfect Success in HIV Prevention Trials, Signaling End of Daily Pill Regimen

Charts, maps and images

The generic formulation will cost $40 per person per year, aligning with the price of daily oral preventative pills.From: FDA Approves First Generic Twice-Yearly HIV Prevention Shot for Developing Nations ·
The 16-month turnaround marks one of the fastest generic approvals for a major HIV innovation to date.From: FDA Approves First Generic Twice-Yearly HIV Prevention Shot for Developing Nations ·
In the PURPOSE 1 trial, the twice-yearly injection recorded zero HIV infections among 2,134 participants.From: Twice-Yearly Shot Achieves Near-Perfect Success in HIV Prevention Trials, Signaling End of Daily Pill Regimen ·
Lenacapavir acts as a capsid inhibitor, binding to the virus's protective shell and disrupting multiple stages of its lifecycle.From: Twice-Yearly Shot Achieves Near-Perfect Success in HIV Prevention Trials, Signaling End of Daily Pill Regimen ·
Dr. Reddy's Laboratories utilized the FDA's 505(b)(2) regulatory pathway to secure a priority review for the generic injection.From: FDA Approves First Generic Twice-Yearly HIV Prevention Shot for Developing Nations ·
Scaling up global manufacturing and generic licensing will be critical to ensuring equitable access in resource-limited nations.From: Twice-Yearly Shot Achieves Near-Perfect Success in HIV Prevention Trials, Signaling End of Daily Pill Regimen ·

Timeline

November 2026

  1. FDA Approves First Generic Twice-Yearly HIV Prevention Shot for Developing Nations

June 2026

  1. Twice-Yearly Shot Achieves Near-Perfect Success in HIV Prevention Trials, Signaling End of Daily Pill Regimen