FDA puts Gilead's Lenacapavir studies in HIV on hold due to vial quality concerns

seekingalpha2021-12-22

Gilead Sciences(NASDAQ:GILD)announces that the FDA has placed a clinical hold on the use of injectable lenacapavir in borosilicate vials in all ongoing clinical studies for HIV treatment and HIV pre-...

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Jliang
2021-12-22
Jliang
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href=https://seekingalpha.com/news/3782552-fda-puts-gileads-lenacapavir-studies-in-hiv-on-hold-due-to-vial-quality-concerns><strong>seekingalpha</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Gilead Sciences(NASDAQ:GILD)announces that the FDA has placed a clinical hold on the use of injectable lenacapavir in borosilicate vials in all ongoing clinical studies for HIV treatment and HIV pre-...</p>\n\n<a href=\"https://seekingalpha.com/news/3782552-fda-puts-gileads-lenacapavir-studies-in-hiv-on-hold-due-to-vial-quality-concerns\">网页链接</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"GILD","symbol_name":"吉利德科学","start_time":0,"source_url":"https://seekingalpha.com/news/3782552-fda-puts-gileads-lenacapavir-studies-in-hiv-on-hold-due-to-vial-quality-concerns","article_id":"1158404163","we_media_id":null,"thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=1158404163","pubTimestamp":1640158909,"sourceInfo":{"source_id":"seekingalpha","name":"Seeking Alpha"},"weMediaInfo":null,"summary":"Gilead Sciences(NASDAQ:GILD)announces that the FDA has placed a clinical hold on the use of injectab","collect":0,"end_time":0,"defaultTopTitle":"seekingalpha.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"GILD":"吉利德科学"},"translate_title":"由于小瓶质量问题，FDA搁置了Gilead的Lenacapavir艾滋病毒研究","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"GILD":0.9},"content_text":"Gilead Sciences(NASDAQ:GILD)announces that the FDA has placed a clinical hold on the use of injectable lenacapavir in borosilicate vials in all ongoing clinical studies for HIV treatment and HIV pre-exposure prophylaxis (PrEP).\nThe FDA’s clinical hold is due to emerging concerns about the compatibility of vials made of borosilicate glass with lenacapavir solution, which could potentially lead to the formation of sub-visible glass particles in the solution of lenacapavir.\nDosing of oral formulations of lenacapavir will continue.\nThe following are some of the studies that have been placed on clinical hold:\nA Phase 2/3 study to evaluate GS-6207 in combination with an optimized background regimen in people with HIV-1 infection with multidrug resistance.\nA Phase 2 of GS-6207 in combination with other antiretroviral agents in HIV.\nA Phase 1 Study in healthy participants to evaluate safety, tolerability, and pharmacokinetics of Lenacapavir.\nA Phase 3 study to evaluate Lenacapavir, and daily oral emtricitabine/tenofovir alafenamide for PrEP in adolescent girls and young women at risk of HIV.\nA Phase 3 study to evaluate the twice yearly Lenacapavir for HIV PrEP in cisgender men, transgender women, transgender men, and gender non-binary people ≥ 16 years of age at risk for HIV infection.\nA Phase 1b study to evaluate GS-5423 and GS-2872 in combination with GS-6207 in virologically suppressed adults with HIV-1.\nLenacapavir is Gilead’s investigational long-acting HIV-1 capsid inhibitor in development for the treatment and prevention of HIV-1 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