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FDA approves generic twice-yearly HIV prevention shot for poorer countries

Lenacapavir from India's Dr. Reddy's is expected to cost $40 a year per person, against $28,218 for Gilead's brand version in the US.

3 news outlets reported this
Liberal2 outletsAffordable access, speed of approval, and funding gapsCenter0 outletslittle coverageConservative1 outletHope for cheap HIV shot in poorer countries
Published 3 min readMoney and daily life
Overview

The US Food and Drug Administration has cleared a generic form of lenacapavir, a shot taken twice a year to prevent HIV. The drug's maker and partner organizations announced the decision on Monday. India's Dr. Reddy's Laboratories developed the generic.

Unitaid, the Clinton Health Access Initiative and Wits RHI, an African health research institute, brokered the deal behind it. The generic is meant for 120 low- and middle-income countries and is expected to cost $40 per person a year. Gilead Sciences' brand version, Yeztugo, was approved last year and has a US list price of $28,218 a year.

Because that version is still under patent, the generic cannot be sold in the US, and the approval is considered tentative. Gilead has been the only supplier until now. It licensed six generic makers, and the other makers' versions have not yet been approved by the FDA.

The Independent reports that Zambia is expected to be among the first to get the generic, before 2026 ends, and that Unitaid hopes supplies arrive by World Aids Day on 1 December. Those helping with the effort say some places could get it within weeks, and others later if they require their own approval.

Key figures
  • $40 a year per person expected cost of the generic in the countries where it will be available — ABC News
  • $28,218 a year US list price of Gilead's brand version, Yeztugo — ABC News
  • 120 low- and middle-income countries where the generic is meant to be available — ABC News
  • 175,000 people have received one dose lenacapavir recipients so far, according to Unitaid — The Independent (US)
  • 570,000 died from HIV-related causes last year HIV deaths, according to the WHO — ABC News

Three sides of the story

Liberal2 outlets

Affordable access, speed of approval, and funding gaps

The Independent leads with a "major step towards ending Aids," describing the twice-yearly jab as "the closest thing the world has to a vaccine." It leans on Unitaid's Carmen Pérez Casas, who says the generic arrived in under 16 months after Gilead's version, when "normally, you require around a decade." It also reports the gaps: the 120 licensed countries leave out nations with at least 10 per cent of global infections, including Brazil.

It ties the news to aid cuts by the US, the UK and other European countries. ABC News is headlined "raises hopes in low-income countries" and opens with the FDA approval. It quotes Carolyn Amole of the Clinton Health Access Initiative on scaling up to the 20 million people who need PrEP.

She adds that "the work is not done," because funding and delivery remain. ABC also carries a Gilead spokesperson's statement on urgency and notes the HIV testing required before each injection and the "tentative" FDA status.

Center0 outlets

Little coverage from centrist outlets

Outlets on this side gave the story little coverage.

Conservative1 outlet

Hope for cheap HIV shot in poorer countries

The Washington Times headlines the story as an approval that "raises hopes in low-income countries." It reports that the FDA has cleared a generic form of lenacapavir, the HIV prevention shot given twice a year. The Times calls this a big step toward cheaper and faster supply across 120 low- and middle-income countries.

Money and daily life

In the 120 covered countries, the generic is expected to cost $40 per person a year, according to ABC News. People must test for HIV before starting and at each injection. In the US the generic cannot be sold, and Gilead's brand version has a list price of $28,218 a year before insurance.

All sources: 4 articles from 3 outlets

Liberal (3)

Conservative (1)