FDA Accepts NDA for Gilead's New HIV Prevention Shot

Gilead Sciences, Inc. recently announced that the FDA accepted its new drug application (NDA) for Sunlenca (lenacapavir) for prevention of HIV.

Lenacapavir is a twice-yearly injectable medication designed to be used as pre-exposure prophylaxis (PrEP). The FDA is giving this drug a priority review and expects to make a decision by June 19, 2025, according to a release.

This review follows the FDA’s decision to grant lenacapavir a breakthrough therapy designation in October 2024.

This drug designation is given to therapies that show early evidence of significant improvement over current treatments for serious conditions.

If approved, lenacapavir would be the first PrEP option that only needs to be taken twice a year, making HIV prevention much more convenient for people who find daily pills hard to manage.

This new option would be a significant change compared to the current PrEP options.

Currently, two oral PrEP drugs — Truvada and Descovy — are available in the U.S., but they need to be taken every day to work effectively. There is also an injectable PrEP called Apretude, but it requires doses every two months. Lenacapavir’s twice-a-year dosage could make it easier for people to stick to their HIV prevention plan.

The NDA approval of lenacapavir is supported by data from two Phase 3 clinical trials, PURPOSE 1 and PURPOSE 2.

In the PURPOSE 1 trial, there were no HIV infections among the participants who received lenacapavir, showing 100% effectiveness compared to the typical HIV rates among cisgender women.

In PURPOSE 2, lenacapavir was 96% effective, with only two participants getting HIV out of a large group that included cisgender men and gender-diverse people. The drug also performed better than the daily oral PrEP option, Truvada, and was generally safe with no major side effects.

Due to these results, Science Magazine named lenacapavir as the “Breakthrough of the Year” in December 2024. If approved, lenacapavir could offer a more flexible and effective HIV prevention option for a diverse range of people.

However, lenacapavir’s high cost could be a barrier.

A report in the Journal of Antimicrobial Chemotherapy noted that the drug might cost as much as $44,819 per person per year. This raises concerns about whether insurance companies will cover the medication.

“Insurers are disincentivized to cover really expensive drugs,” Abrigo said in an interview with Managed Healthcare Executive. “Because insurance companies don't want to spend money, if there is a viable alternative, they will deny it and say, ‘take the others.’ That analysis isn't fully informed sometimes because sometimes the medical records submitted to them are incomplete, doctors don't know how to word the request and just the default for most insurers to deny.”

Gilead is aware of these challenges and is working on a global access strategy to make lenacapavir available to more people, according to the release.

These efforts include seeking regulatory approval not just in the U.S. but also in Europe and low- and middle-income countries.

By working with health organizations and regulators worldwide, Gilead hopes to speed up the approval process and make lenacapavir more affordable and accessible.

Accodring to the release, lenacapavir is unique because it works differently from other HIV drugs.

Most antiviral medications target only one stage of the HIV lifecycle, but lenacapavir acts at multiple stages, reducing the risk of resistance. This makes it a promising option not just for prevention but also as a foundation for future HIV treatments.

Currently, lenacapavir is approved for treating adults with multi-drug resistant HIV, but its use for HIV prevention is still experimental.

The FDA has not yet confirmed its safety and effectiveness for this purpose, but the positive trial results and priority review suggest that lenacapavir could play a significant role in the future of HIV prevention.

For over 35 years, Gilead has been a leader in HIV research, developing 12 HIV medications, including the first single-tablet regimen and the first long-acting injectable HIV treatment. With lenacapavir, Gilead aims to continue innovating and helping to end the HIV epidemic worldwide.

The FDA’s decision is expected by June 2025.