FDA 暂定批准 Dr. Reddy's 的 lenacapavir 仿制版用于 HIV 预防
STAT+: FDA OKs generic HIV prevention shot, widening access for lower-income countries
FDA 已向 Dr. Reddy's Laboratories 发出 lenacapavir 仿制版的暂定批准，用于 HIV 预防，这是扩大中低收入国家可及性的关键一步。Dr. Reddy's 计划下个月开始发货，每人每年费用为 40 美元，与每日口服片剂相当。原研药由 Gilead Sciences 以 Yetzugo 品牌在美国销售，去年获 FDA 批准，每六个月注射一次。
FDA 对 lenacapavir 仿制药的暂定批准，让读者了解中低收入国家可及性的价格与供货节奏。
By Ed Silverman
Nov. 2, 2026
Pharmalot Columnist, Senior Writer
Ed’s stories explore prescription drug pricing, affordability and access, as well issues surrounding patents, litigation, and legislation. He is also the author of the morning Pharmalittle newsletter and the afternoon Pharmalot newsletter.
After months of anticipation, the Food and Drug Administration gave tentative approval to Dr. Reddy’s Laboratories to make a generic version of a groundbreaking HIV prevention medicine, a key step in widening access for dozens of low- and middle-income countries.
The company, one of the world’s largest generic drugmakers, plans to start shipping the medicine next month as part of an effort propelled, in part, by several global health organizations to ensure the drug becomes available in lower-income countries as quickly as possible. The annual cost per person will be $40, comparable to daily tablets.
Known as lenacapavir, the injectable drug is widely seen as a game-changing tool for eradicating HIV because it offers virtually complete protection against contracting the virus with just one administration every six months. The brand-name version, which is known as Yetzugo in the U.S., is marketed by Gilead Sciences and was approved by the FDA last year.
STAT+ Exclusive Story
Already have an account? Log in
This article is exclusive to STAT+ subscribers
Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts.
Already have an account? Log in
To read the rest of this story subscribe to STAT+.
来源：STAT News · statnews.com