The US Food and Drug Administration (FDA) has granted temporary approval to Indian pharmaceutical company Dr. Reddy's for a generic version of lenacapavir, a long-acting injectable HIV preventive drug. This development is expected to increase access to pre-exposure prophylaxis (PrEP) in low- and middle-income countries. The generic version will be priced at $40 per person per year in 120 countries.
Lenacapavir, initially developed by Gilead Sciences, is a long-acting antiretroviral drug that requires only two injections per year, six months apart, unlike daily oral medication. Clinical trials have shown that the drug is highly effective in preventing HIV infection, with a reduction in risk of nearly 100%. In the PURPOSE 1 trial, no infections were observed among participants who received lenacapavir.
The original branded version of lenacapavir, marketed as Sunlenca in the US, has a list price of over $28,000 per person per year. In contrast, the generic version developed by Dr. Reddy's will be significantly cheaper, at $40 per person per year. This price reduction is expected to make the drug more accessible to people in low- and middle-income countries.
The development of the generic version was supported by several organizations, including Unitaid, the Clinton Health Access Initiative (CHAI), and the Wits Reproductive Health and HIV Institute (Wits RHI). These organizations partnered with Dr. Reddy's to accelerate the development and introduction of the generic version in countries where it is needed.
The first shipments of the generic lenacapavir are expected to be delivered by the end of 2026, with wider deployment planned for 2027. However, it is essential to note that lenacapavir is a preventive medication, not a treatment for HIV. Its use requires prior testing and regular monitoring to rule out existing infection and minimize the risk of resistance.
The approval of the generic lenacapavir is a significant step forward in the fight against HIV. However, the challenge lies in ensuring that the drug reaches the people who need it most. Efforts will be needed to ensure that the generic version is widely available and accessible to those who require it.
The introduction of the generic lenacapavir is expected to have a significant impact on HIV prevention in countries where access to PrEP has been limited due to cost. The long-acting injectable formulation may also help to increase adherence to treatment, as it eliminates the need for daily oral medication.
Key points
- The generic version of lenacapavir will be priced at $40 per person per year in 120 countries.
- The drug requires only two injections per year, six months apart.
- The generic version was developed with the support of Unitaid, CHAI, and Wits RHI.
