Overview
- The first doses of lenacapavir have reached Eswatini and Zambia, beginning the drug’s rollout in sub-Saharan Africa.
- Lenacapavir is already approved in South Africa and Zambia, with regulatory filings submitted for eight more African countries and further submissions targeted by the end of 2025.
- Gilead has pledged to supply the medicine at no profit for up to two million people until manufacturers can meet demand in Global Fund and PEPFAR-supported countries.
- Gilead granted voluntary licences to Dr Reddy’s, Emcure, Hetero and others, but Indian generics are not yet available as activists cite slow clearances, a trial-waiver rejection, and ongoing patent actions.
- Advocates have urged India’s DCGI to grant a waiver under NDCTR rules and say faster decisions could enable low-cost generics estimated at US$25–40 per person per year.