A file shot of Dr Reddy’s Labs headquarters in Hyderabad.
Hyderabad: Dr Reddy’s Laboratories said Monday US Food and Drug Administration has granted tentative approval for its twice-yearly injectable lenacapavir for pre-exposure prophylaxis, or PrEP, to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35 kg. The approval, issued under USFDA’s President’s Emergency Plan for AIDS Relief (PEPFAR) programme, moves the long-acting HIV prevention medicine closer to use in 120 countries outside the United States covered by Gilead Sciences’ voluntary licence. Dr Reddy’s said wider rollout still requires WHO prequalification and national regulatory approvals with HIV-negative status to be confirmed before initiation and before each subsequent injection.
“For someone at risk of HIV, taking a pill every day to prevent a disease they don’t have is a hard thing to ask,” said Dr Neil Buddy Shah, CEO, CHAI, calling two injections yearly “almost 100% effective” and a “new standard for global health. World Health Organization recommends twice-yearly lenacapavir for HIV prevention.