Dr. Reddy’s Laboratories has secured FDA tentative approval for the first generic injectable lenacapavir, 16 months after Gilead’s originator product was approved for HIV prevention, the Clinton Health Access Initiative said. [E1]
CBC described lenacapavir as the world’s only twice-yearly shot to prevent HIV and said the approval was a big step toward making it available more quickly and inexpensively in low- and middle-income countries. [E2]
The FDA status is tentative, its standard designation for generics while the originator remains under patent, CBC said. [E3]
Under the existing partnership agreement, the injection will be available at $40 a person a year in the 120 low- and middle-income countries covered by Gilead’s voluntary licence, CHAI said. [E4]
First supplies are expected to reach countries before the end of 2026, with broader availability in 2027, CHAI said. [E5]