“吉利德的科学家们开发了Sunlenca这种独特而有效的抗逆转录病毒药物,具有灵活的剂量选择潜力。我们的目标是提供多种适合HIV感染者和可能受益于PrEP药物的人的治疗和预防的长效选择。” Sunlenca的FDA批准得到了来自第2/3期CAPELLA试验的数据的支持,该试验评估了与优化的背景疗法联合使用的lenacapavir在多重耐药性...
1.Gilead wins approval for long-acting HIV injection after resolving vial concerns;Endpoints News 2.GILD:Q322 Financial Results;Gilead 3.首款HIV衣壳抑制剂诞生,吉利德的基本盘稳了?;写意宣发 4.长效HIV疗法竞争白热化,吉利德重新向FDA提交Lena...
Gilead wins approval for long-acting HIV injection after resolving vial concerns;Endpoints News GILD:Q322 Financial Results;Gilead 首款HIV衣壳抑制剂诞生,吉利德的基本盘稳了?;写意宣发 长效HIV疗法竞争白热化,吉利德重新向FDA提交Lenacapavir上市申请;同写意 世界必须“加快”努力,到2030年终结艾滋病流行;联合...
现阶段,吉利德还开展了lenacapavir与其他疗法联合用于感染已经被抑制的患者的试验,以及评估Lenacapavir作为暴露前预防(PrEP)用途的研究,后者该数据预计在2024年发布。 主要参考资料: 1. Gilead Announces First Global Regulatory Approval of Sunlenca® (Lenacapavir), the Only Twice-Yearly HIV Treatment Option;...
吉利德预计2025年的销售额将在282亿至286亿美元之间,尽管该公司尚未透露lenacapavir PrEP 推出将如何影响这一总数。除了2025年夏季预期的 FDA 决定外,该公司还希望在2033年前推出七种新的潜在治疗方法,其中一些使用 lenacapavir 作为组成部分。17.拜耳公司 作者:凯文·邓利维 2024年收入:240亿欧元(260亿美元) ...
Truvada is a two-drug combination of emtricitabine and tenofovir disoproxil fumarate, approved for the treatment of HIV-1 infection and PrEP. The strong results from the PURPOSE increase the probability of lenacapavir’s approval, which should further solidify GILD’s HIV franchise. Lenacapavir has...
uncertainties relating to regulatory applications and related filing and approval timelines, including the New Drug Applications seeking FDA approval and the MAA and EU-M4all seeking EMA approval of lenacapavir for PrEP, a...
uncertainties relating to regulatory applications and related filing and approval timelines, including the New Drug Applications seeking FDA approval and the MAA and EU-M4all seeking EMA approval of lenacapavir for PrEP, and the risk that any regulatory approvals, if granted, may b...
This approach aims to help address the individual needs and preferences of people with HIV and people who could benefit from pre-exposure prophylaxis (PrEP). The use of lenacapavir for HIV prevention is investigational and ...
• Initiation of studies through this RFP will be contingent upon FDA approval of lenacapavir for PrEP in the population being studied. • Requests for drug supply will not be considered if the provision of drug impacts the question being addressed. For example...