The U.S. Food and Drug Administration has granted tentative approval to Dr. Reddy’s Laboratories to produce a generic version of lenacapavir, an HIV prevention medicine considered a major step toward expanding access in dozens of low- and middle-income countries.
The Indian pharmaceutical company plans to begin shipping the medicine next month. The effort has been supported in part by global health organizations seeking to make the drug available in lower-income countries as quickly as possible.
The annual cost is expected to be $40 per person, comparable to the cost of daily HIV prevention tablets.
Lenacapavir is an injectable medicine administered once every six months and is widely viewed as a potentially transformative tool in HIV prevention because it offers virtually complete protection against contracting the virus. Gilead Sciences markets the brand-name version in the United States under the name Yetzugo, which received FDA approval last year.
Sources: STAT News.