Generic biannual HIV drug gets FDA approval

The US Food and Drug Administration (FDA) has granted tentative approval to a generic version of the world's only twice-yearly injectable HIV prevention drug, lenacapavir, paving the way for affordable preventive care in 120 low- and middle-income countries.

Global health agencies project that the generic drug will cost $40 per person annually in designated recipient countries across sub-Saharan Africa, Asia and Latin America, The Independent reports.

This matches the current price of daily oral pre-exposure prophylaxis (PrEP) tablets while offering a far more convenient dosing schedule. Clinical trials showed that the twice-yearly injections virtually eliminated new HIV infections among high-risk participants.

India-based Dr Reddy's Laboratories developed the generic medication through an international consortium involving Unitaid, the Clinton Health Access Initiative and South African research institute Wits RHI.

According to The Independent, the brand-name version, Yeztugo, carries an annual US list price of $28,218 and remains under patent protection, preventing generic sales in the US market.

Health experts say expanding access to PrEP among the 20 million people globally who need it could significantly curb HIV transmission and reduce AIDS-related deaths.

Patients must undergo rapid HIV testing before each injection, as administering lenacapavir to people with undiagnosed HIV infections risks the development of drug-resistant virus strains. Initial distribution in selected recipient countries is scheduled to begin within weeks.