Source: GlobalData
Gilead’s lenacapavir could revolutionize HIV prevention, says GlobalData
Posted in Pharma
Gilead Sciences has announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submissions for lenacapavir for HIV prevention. Lenacapavir was granted Breakthrough Therapy Designation for HIV prevention by the FDA in October 2024 and will be reviewed by the FDA under priority review. The FDA has set a target action date of June 19, 2025, under the Prescription Drug User Fee Act (PDUFA). If approved, lenacapavir has the potential to revolutionize HIV pre-exposure prophylaxis (PrEP), says GlobalData, a leading data and analytics company.
Stephanie Kurdach, Infectious Disease Analyst at GlobalData, comments: “Gilead’s lenacapavir, an HIV-1 capsid inhibitor, is already marketed in the US, EU, and numerous other countries, under the brand name Sunlenca, for the treatment of adults with multidrug-resistant HIV. If approved by the FDA, lenacapavir will become the first and only twice-yearly injectable for HIV PrEP.”
Conventional PrEP is administered orally once daily, but according to Phase III clinical trial data, lenacapavir demonstrated superiority in preventing HIV infections when compared with the once daily comparator, Truvada (emtricitabine/tenofovir disoproxil fumarate). Further, lenacapavir was generally well-tolerated with no new safety concerns observed.
Key opinion leaders (KOLs) interviewed by GlobalData have expressed positive opinions on the development of lenacapavir for PrEP. KOLs were largely in agreement that the trial data was impressive, and the route of administration and frequency of administration make lenacapavir a practical and promising option, although they also expressed concerns about cost, long term efficacy, and the potential development of resistance mechanisms.
Kurdach continues: “Lenacapavir’s route of administration and frequency of administration make it an enticing option for PrEP, not only for those at-risk of HIV infection in the US, but also in areas where adherence to a daily oral PrEP regimen is low, such as sub-Saharan Africa.”
Gilead also recently announced the submission of marketing authorization applications to the European Medicines Agency (EMA) for lenacapavir for PrEP. One of the applications seeks European Commission authorization, and the other application would facilitate availability of the PrEP regimen in low- and lower-middle-income countries.
The World Health Organization (WHO) has reported that 2.6 million people received at least one dose of PrEP in the WHO African region in 2023. According to GlobalData epidemiologists, there were 491,201 people receiving PrEP in the US and 263,726 people receiving PrEP in the 5EU* in 2023. Between 2023 and 2033, these numbers are expected to increase by over 30% in the US and by nearly 40% in the 5EU. These projections indicate the need for more convenient PrEP options worldwide.
Kurdach concludes: “Lenacapavir has the potential to transform HIV prevention, which could translate to increased PrEP adherence rates, and lower incident cases of HIV worldwide.”
*France, Germany, Italy, Spain, UK