Two Injections a Year Could Cut HIV Risk: FDA Tentative Approval for Dr Reddy's Generic Drug

A new possibility has emerged to reduce the risk of HIV infection without the burden of taking medicine every day. A generic lenacapavir injection made by Indian drugmaker Dr Reddy's Laboratories has received tentative approval from the US Food and Drug Administration, the FDA, for HIV prevention.

The injection is to be taken once every six months. Taking the injection twice a year would therefore create an opportunity to prevent HIV, the report said.

Lenacapavir was originally developed by US drugmaker Gilead Sciences. In October 2024, Dr Reddy's signed a voluntary licensing agreement with Gilead. Under it, the company will be able to manufacture and supply the drug in 120 low- and middle-income countries including India.

On 2 November 2026, Dr Reddy's generic drug received the FDA's 'tentative approval'. The approval could further widen the path to making the drug easily available worldwide. However, because of patent-related restrictions in the United States, this approval is not a licence to market it directly there.

Lenacapavir works by targeting the capsid protein of the HIV-1 virus and disrupting multiple stages of the virus's life cycle, hampering viral replication and the spread of infection. This preventive use of the drug is called pre-exposure prophylaxis, or PrEP - it is used to protect people at risk of HIV before they become infected.

Lenacapavir is not, however, a cure for HIV. This preventive dose cannot be used to treat people who already have HIV in their bodies. Lenacapavir has a separate use in treating people living with HIV, but that must be done with other antiretroviral drugs under a specific treatment plan.

Use of the drug has been approved for adults and adolescents above a specified weight who are at risk of HIV infection. Before taking the injection, an HIV test must confirm there is no infection in the body, and testing is essential before every subsequent dose as well, because taking the drug with an undetected infection could create a risk of the virus becoming drug-resistant.

The injection does not protect against other sexually transmitted infections. Following a doctor's advice and necessary precautions is therefore essential; the drug must not be taken on one's own, and the need for regular testing cannot be avoided either.

The first supplies of Dr Reddy's generic drug could reach some countries in late 2026, related organisations have said, with a plan for wider supply in 2027. The target is to supply the drug at 40 US dollars per person per year in the 120 countries covered by the licence. Final marketing approval in India, and when it will be available in countries including Bangladesh, will depend on the decisions of the respective regulators and on supply.