Lenacapavir – BiotechReality – Information Intelligence System for Biopharma

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion under accelerated review, recommending lenacapavir, the company's injectable HIV-1 capsid inhibitor, for use as pre-exposure prophylaxis (PrEP) to lower the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk, according to a statement released today by Gilead Sciences, Inc. (Nasdaq: GILD). Lenacapavir will be sold in the European Union (EU) under the trade name Yeytuo® if the final European Commission (EC) decision is accepted, which is anticipated later this year. As it assesses lenacapavir as a possible novel HIV prevention strategy in all 27 EU Member States, as well as Norway, Iceland, and Liechtenstein, the EU will now analyze the marketing authorization application (MAA) suggestion. Furthermore, lenacapavir will have an extra year of market exclusivity in the EU due to the new indication if it is approved. Read More: Gilead Unveils Promising New Data on Twice-Yearly HIV Prevention Drug Lenacapavir This milestone reflects our commitment to reimagine HIV prevention in Europe and around the world, Lenacapavir for PrEP has the potential to become a critical tool for public health, helping to expand prevention options for people who face the highest barriers to care. Dietmar Berger Additionally, the CHMP adopted a favorable EU-Medicines for all (EU-M4all) opinion, which will facilitate national regulatory evaluations in low- and lower-middle-income countries (LLMICs) and allow for a simplified assessment for World Health Organization (WHO) prequalification. Read More: Gilead Provides Clinical Update on Investigational HIV-1 Treatments GS-1720 and GS-4182 Disparities in PrEP use persist due to enduring social and economic factors, such as stigma and discrimination, despite continuous advancements in HIV prevention. Thirty EU/European Economic Area nations reported 24,731 new HIV infections in 2023, an increase of 11.8% over 2022. Data from Gilead's Phase 3 PURPOSE 1 and PURPOSE 2 trials corroborated the favorable views. According to data from the primary analysis of the PURPOSE 1 trial (NCT04994509), in cisgender women in sub-Saharan Africa, twice-yearly subcutaneous lenacapavir administration resulted in zero HIV infections among 2,134 participants, a 100% reduction in HIV infections, and superior HIV infection prevention when compared to once-daily oral Truvada® (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg; F/TDF). Two HIV infections occurred among 2,179 participants in the twice-yearly subcutaneous lenacapavir group of the PURPOSE 2 trial (NCT04925752), indicating that 99.9% of participants did not contract HIV and that the twice-daily oral Truvada group was superior in preventing HIV infections across a wide range of geographic. When compared to background HIV incidence (bHIV), lenacapavir showed superiority in preventing HIV infections in both trials. It was also generally well-tolerated, with no new or severe safety concerns found. The New England Journal of Medicine published data from both studies, and the magazine Science named lenacapavir its 2024 "Breakthrough of the Year" in December 2024, partly because of the trial's outcomes. Information: Gilead Sciences

Tag: Lenacapavir

Gilead’s Lenacapavir for HIV Prevention Gets Positive CHMP Nod

Gilead Unveils Promising New Data on Twice-Yearly HIV Prevention Drug Lenacapavir

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