Gilead, ‘closely attuned to’ potential US policy shifts, stands by long-acting PrEP launch

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Gilead Confirms Commitment to Lenacapavir Long-Acting PrEP Launch Amid Policy Uncertainties

Gilead Sciences is preparing to launch lenacapavir, its long-acting injectable HIV pre-exposure prophylaxis (PrEP), despite ongoing uncertainties around potential US policy changes2.
Lenacapavir is a twice-yearly injectable HIV-1 capsid inhibitor, positioned as a significant innovation in HIV prevention, with the company anticipating substantial market growth and interest from PrEP-naïve populations1 2.
The US Food and Drug Administration (FDA) has accepted Gilead’s new drug application for lenacapavir for HIV prevention, granting it priority review status with a decision expected by June 19, 20251 2.
Lenacapavir previously received Breakthrough Therapy Designation from the FDA, highlighting its potential to substantially improve clinical outcomes over existing therapies1.
Gilead’s launch strategy includes a targeted plan for the first 30 and 90 days post-approval, with dedicated marketing, sales, and nurse education teams ready for deployment2.
Clinical evidence supports lenacapavir's efficacy and potential to help address challenges with PrEP adherence and persistence, with Phase III trials for even longer-acting (once-yearly) formulations planned3 4 5.
The company remains “closely attuned” to possible shifts in US health policy that may affect market access or pricing but maintains readiness to introduce lenacapavir as scheduled2.
Interest in the long-acting option is high, with expectations that its launch will rapidly expand the current PrEP market2.