美国食品药品监督管理局（FDA）批准两种“同情用药”用于治疗新冠肺炎 COVID-19

美国网站Pharmacy Times最新消息：

1．美国食品药品监督管理局（FDA）局长史蒂芬 · 哈恩和总统唐纳德 · 特朗普表示，氯喹(Chloroquine）和瑞德西韦（Remdesivir）将作为研究用药用于新冠病毒的治疗，范围仅限于

重症患者。

2.  氯喹，或称羟氯喹，目前已被美国食品药品监督管理局（FDA）批准用于治疗疟疾、狼疮和类风湿性关节炎，但并不适用于新冠病毒，但它作为一种血红素聚合酶抑制剂正在被测试是否能提高病毒清除率 。

3．瑞德西韦是一种具有广谱抗病毒活性的核苷酸类似物，根据它的制造商 Gilead Sciences 的说法，目前它没有被美国食品药品监督管理局（FDA）或任何其他国家批准使用。 然而，瑞德西韦已经证明对中东呼吸综合症和非典有活性，表明它可能对COVID-19有潜在的活性。 

4．在周四的白宫新闻发布会上，史蒂芬 · 哈恩说，尽管瑞德西韦仍处于研究阶段，但是这场史无前例的流感大流行需要采取行动。 “瑞德西韦正在经历正常的临床过程。 我们确实需要了解产品的安全性和有效性。”

史蒂芬 · 哈恩说：“今年一月份以来，美国食品药品监督管理局（FDA）一直在与疾病控制和预防中心合作抗击这种病毒。 目前FDA正在提供灵活性的监管和指导，但同时也在继续确保产品的安全性。 这项工作的一个重要部分是扩大冠状病毒的治疗选择”

特朗普说：“这些药物将通过处方提供。” 但哈恩还是拒绝透露这两种药物何时可用于COVID-19患者。

 

https://www.pharmacytimes.com/news/fda-announces-two-drugs-approved-for-compassionate-use-in-treating-covid-19

 

FDA Announces Two Drugs Approved for ‘Compassionate Use’ in Treating COVID-19

2020-03-19 17:40:00

Kristen Coppock, MA, Managing Editor

Two drugs, chloroquine and remdesivir, are being designated for Expanded Access, or “compassionate use,” by the FDA to address the novel coronavirus (COVID-19) pandemic, according to FDA Commissioner Stephen Hahn, MD, and President Donald Trump.1

Chloroquine and remdesivir are not FDA-approved for a COVID-19 indications, but Expanded Access allows patients with serious or life-threatening cases of the virus to have access to them as investigational medicinal products.2

Chloroquine, or hydroxychloroquine, is currently approved by the FDA for treatment of malaria, lupus, and rheumatoid arthritis, although not for COVID-19. A heme polymerase inhibitor, the drug is being tested for possible COVID-19 use to improve virologic clearance.3

Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity, according to its maker, Gilead Sciences, and it is not approved by the FDA nor any other countries for any use. However, remdesivir has demonstrated activity against MERS and SARS, indicating that it may have potential activity against COVID-19. The drug has been used in a small number of patients with COVID-19 in an experimental manner, according to Gilead.4

During a White House press conference on Thursday, Hahn said that although remdesivir is still in its investigational phase, the unprecedented pandemic warranted action. “Remdesivir is [still] going through the normal process. We do need to know about the safety and effectiveness,” he said.1

According to Hahn, the FDA is providing regulatory flexibility and guidance, but is also continuing to ensure products are safe. He said the agency has been working with the CDC since January on combating the virus.1

“An important part of that work is expanding therapeutic options for the coronavirus,” Hahn said.1

Trump said these medications will be made available by prescription. Hahn declined to say when both drugs would become available for use in patients with COVID-19.1

For up-to-date information on COVID-19 for pharmacy professionals, visit Pharmacy Times' coronavirus resource center.

 

 

参考文献

 

1.Coronavirus Task Force. White House Press Conference. Presented: March 19, 2020. Accessed March 19, 2020.

 

2.FDA. Expanded Access. FDA website. https://www.fda.gov/news-events/public-health-focus/expanded-accessUpdated May 6, 2019. Accessed March 19, 2020.

 

 

3.Bulloch M. Potential Pipeline Medications May Help Patients with Novel Coronavirus. PharmacyTimes.https://www.pharmacytimes.com/news/potential-pipeline-medications-for-the-coronavirus Published March 11, 2020. Accessed March 19, 2020.

 

4.Gilead Sciences. Gilead Sciences Update On the Company’s Ongoing Response to COVID-19. Gilead Sciences website. https://www.gilead.com/purpose/advancing-global-health/covid-19 Updated February 26, 2020. Accessed March 20, 2020.