瑞德西韦|瑞德西韦在美获批上市，官方盖章意味着“效果好”吗？( 三 )
批评人士指出，新药上市将影响未来市场走向 。委员会成员之一、加州大学洛杉矶分校的HIV/AIDS科学家大卫·哈迪（David Hardy）惊讶于政府越过了外部咨询，“这为第一个抗新冠病毒药物设置了标准”，“当要给制药公司市场独占权，这是非常、非常重要的事情 。” [2]
10月22日瑞德西韦获批的消息公布后，吉利德的股价在盘后交易中上涨3.8%[15] 。
今年4月，曹彬与王业明团队瑞德西韦对重症治疗无效的研究公布后，《知识分子》曾采访德泰迈医药科技有限公司创始人和董事长李浩 。李浩当时表示，即使后续瑞德西韦的临床试验试验全部无效，对制药这个行当来说，也是正常的，因为平均来说，药物成功上市的概率本来就不高 。[16]
如此看来，瑞德西韦作为搁浅在研药快速上市真的非常幸运 。
当然，更为幸运的也许是吉利德公司 。当瑞德西韦不再作为捐赠品和试验赞助，其对发达国家政府的定价为单瓶390美元，一个五天的疗程需2340美元 [17] 。不过，据美国医学媒体STAT报道，美国有商业保险的患者将被收取更高的费用，单瓶520美元，五天疗程3120美元 。STAT的报道还透露，美国政府预计将花数十亿美元购买瑞德西韦 [18] 。而在WHO公布团结试验结果之前，欧盟已与吉利德在10月8日签下了10亿欧元大单 [19] 。
参考文献
[1]FDA Approves First Treatment for COVID-19
https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19
[2] The ‘very, very bad look’ of remdesivir, the first FDA-approved COVID-19 drug.
https://www.sciencemag.org/news/2020/10/very-very-bad-look-remdesivir-first-fda-approved-covid-19-drug
[3]Gilead’s Covid-19 Drug Is Mediocre. It Will Be a Blockbuster Anyway.
https://www.nytimes.com/2020/10/29/health/covid-remdesivir-gilead.html
[4]Beigel et al., Remdesivir for the Treatment of Covid-19 — Final Report. The New England Journal of Medicine. DOI: 10.1056/NEJMoa2007764
https://www.nejm.org/doi/full/10.1056/NEJMoa2007764
[5]Spinner et al., Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2020 Sep 15;324(11):1048-1057.
https://pubmed.ncbi.nlm.nih.gov/32821939/
[6]Goldman et al., Remdesivir for 5 or 10 Days in Patients with Severe Covid-19. The New England Journal of Medicine. DOI: 10.1056/NEJMoa2015301
https://pubmed.ncbi.nlm.nih.gov/32459919/
[7] Remdesivir becomes first Covid-19 treatment to receive FDA approval. https://edition.cnn.com/2020/10/22/health/remdesivir-fda-approved-covid-19/index.html
[8] WHO Solidarity trial consortium. Repurposed antiviral drugs for COVID-19–interim WHO SOLIDARITY trial results.
https://www.medrxiv.org/content/10.1101/2020.10.15.20209817v1.full.pdf
[9]Gilead Sciences Statement on the Solidarity Trial.
https://www.gilead.com/news-and-press/company-statements/gilead-sciences-statement-on-the-solidarity-trial
[10]RECOVERY Collaborative Group. Lopinavir–ritonavir in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet 2020; published online Oct 5. https://doi.org/10.1016/ S0140-6736(20)32013-4.
[11]Cao & Hayden, Antiviral monotherapy for hospitalised patients with COVID-19 is not enough. Lancet,(2020) Volume 396, ISSUE 10259, P1310-1311
[12]Wang et al. Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial.Lancet. 2020; 395: 1569-1578
[13] Holshue et al. First Case of 2019 Novel Coronavirus in the United States. The New England Journal of Medicine. 2020; 382:929-936. DOI: 10.1056/NEJMoa2001191
[14]Remarks by President Trump in Announcement on Remdesivir
https://www.whitehouse.gov/briefings-statements/remarks-president-trump-announcement-remdesivir/
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