STAT+：FDA批准仿制HIV预防针剂，扩大低收入国家的可及性
摘要
经过数月的期待，美国食品药品监督管理局（FDA）给予Dr. Reddy's Laboratories临时批准，允许其生产一种开创性HIV预防药物的仿制版本，这是扩大数十个低收入和中等收入国家可及性的关键一步。该公司是全球最大的仿制药生产商之一，计划于下月开始发货，此举部分由多家全球卫生组织推动，以确保该药物尽快在低收入国家上市。每人每年费用将为40美元，与每日口服片剂相当。该注射药物名为lenacapavir，被广泛视为消灭HIV的游戏规则改变者，因为仅需一次注射即可提供几乎完全的病毒防护。
English
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 on