FDA Approves Generic Lenacapavir for HIV, but Brazil Is Left Out of Cheap Distribution
The highly effective twice-yearly injection will reach 120 countries at US$ 40 per person per year; in Brazil, the maximum authorized price is R$ 20,900 per dose.
Translated from the Portuguese original by the Panorama newsroom. Read in Portuguese
Summary written by the Panorama newsroom from the sources listed below. Facts are attributed to the original publications.
The FDA, the US regulatory agency, on Monday (2) approved a generic version of lenacapavir, a twice-yearly injectable to prevent HIV. The announcement was made by India's Dr. Reddy's and by Unitaid, according to Folha.
The approval is temporary: it does not allow sales in the US, but authorizes distribution in developing countries through humanitarian programs. The drug was created by Gilead and approved in the US in June 2025, with efficacy above 99.9% in large trials.
Dr. Reddy's version will be sold at US$ 40 per person per year (about R$ 217) to 120 low- and middle-income countries, among them Ethiopia, Botswana, Mozambique and Vietnam. Brazil, Peru and Mexico are not part of the agreement.
Brazil, which took part in the drug's trials, was also left out of Gilead's voluntary licensing to six generic manufacturers. Anvisa approved its use for prevention in January, but the government is struggling to offer it in the SUS (Brazil's public health system).
In July, Minister Alexandre Padilha called the price "unfeasible." The Medicines Market Regulation Chamber set the maximum price per injection at R$ 20,900.