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PHARMA JOBS POST > Pharma News > 🌟 FDA Greenlights Gilead’s Biannual Injection for HIV Prevention
Pharma News

🌟 FDA Greenlights Gilead’s Biannual Injection for HIV Prevention

Newspress
Last updated: June 25, 2025 2:30 am
Newspress 11 months ago
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In a major breakthrough, the U.S. Food and Drug Administration has approved lenacapavir, marketed as Yeztugo, as the first-ever twice-yearly injectable pre-exposure prophylaxis (PrEP) for HIV prevention in adults and adolescents weighing at least 35 kg .

Contents
What is Yeztugo?💯 Efficacy That’s Nearly UnmatchedWhy This Matters🌟 Spotlight VideoAccess, Costs & Challenges

What is Yeztugo?

  • A capsid inhibitor developed by Gilead Sciences, it works by blocking multiple stages of HIV replication .
  • It is administered as two subcutaneous injections every six months, creating a long-lasting drug depot

💯 Efficacy That’s Nearly Unmatched

  • In the phase 3 PURPOSE 1 and 2 trials, Yeztugo achieved ≥99.9% protection, with zero HIV cases in cisgender women and an overall 99.9% prevention rate.
  • Adherence was stellar—over 91% of participants received on-time injections at 6 and 12 months.

Why This Matters

  • Simplified regimen: Only two visits per year might reduce stigma and improve adherence compared to daily pills (Truvada, Descovy) or bimonthly injections like Apretude .
  • Global potential: Recognized as a 2024 “Breakthrough of the Year” by Science, Gilead is working with generics manufacturers to expand availability in low-income countries.

🌟 Spotlight Video

Access, Costs & Challenges

  • List price is set around $28,000 per year in the U.S., similar to existing brand-name PrEP options .
  • Gilead is planning broad insurance coverage, co-pay help, and partnerships to mitigate cost burdens .
  • However, funding cuts to HIV programs, Medicaid, and global aid may impede access—particularly among marginalized communities .

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TAGGED: FDA, Gilead Sciences, pharma news, UNAIDS, WHO
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