智通财经APP获悉，2月18日，吉利德(GILD.US)宣布FDA已接受lenacapavir用于HIV暴露前预防(PrEP)的新药申请(NDA)，PDUFA预定审批日期为2025年6月19日。Lenacapavir是一款First-in-class HIV-1衣壳抑制剂，给药便利，仅需每半年注射一次。
吉利德首席医学官Dietmar Berger博士表示：“我们距离推出首个每半年一次的HIV预防疗法又近了一步。如果获批，lenacapavir将有助于改变需要或希望获得更多预防选择人们的生活。我们对lenacapavir在美国乃至全球HIV预防中可能产生的积极影响感到兴奋，这将支持我们实现‘让每个人、每个地方终结HIV流行病’的目标。”
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.