The U.S. Food and Drug Administration has approved a generic version of lenacapavir, a twice-yearly injection used to prevent HIV, clearing a path for lower-cost access in 120 low- and middle-income countries.
The approval was announced Monday by the generic drug’s manufacturer and organizations involved in accelerating its development. The medicine is expected to cost about $40 per person per year in the countries where it will be available, the same annual price cited for daily preventive pills.
A longer-acting option
Lenacapavir is a form of pre-exposure prophylaxis, commonly called PrEP. PrEP is prescribed to people who may be exposed to HIV before exposure occurs. Unlike daily pills, the injection is administered only twice a year, a schedule that health advocates say could address one of the main challenges with oral prevention: people may not take a pill every day.
“With lenacapavir, we are much more hopeful,” said Carmen Pérez Casas, HIV lead for Unitaid.
Two large studies involving people at high risk of HIV found that the injections nearly eliminated new infections, according to the information provided about the approval. Pérez Casas said daily prevention cannot provide protection when people do not take the medication.
- 120 countries are expected to receive access to the generic version.
- The projected price is about $40 per person annually.
- The injection is given twice a year, rather than daily.
Global need for prevention
The World Health Organization estimates that 41 million people were living with HIV worldwide last year and that 570,000 people died from HIV-related causes. Carolyn Amole, who leads the HIV program at the Clinton Health Access Initiative, said an affordable generic could help expand PrEP to the estimated 20 million people around the world who need it.
Amole said wider use of the medication could contribute to reducing HIV infections and deaths. Those statements describe the potential public-health effect of expanded access; the approval itself establishes the generic’s authorization and the planned availability in participating countries.
U.S. patent protection
The generic version will not be sold in the United States because the brand-name version, Yeztugo, remains protected by a patent. Gilead Sciences makes Yeztugo, which was approved in the U.S. last year. Its listed price before insurance is $28,218 per year, according to the information provided about the FDA action.
Gilead officials have said that price is similar to the cost of some other forms of PrEP. The generic approval applies to access in the countries included in the agreement and does not make the generic version available for sale in the United States.
