"積了德"放棄"人民的希望"的孤兒藥資格

Gilead Sciences Statement on Request to Rescind Remdesivir Orphan Drug Designation

 

Gilead has submitted a request to the U.S. Food and Drug Administration to rescind the orphan drug designation it was granted for the investigational antiviral remdesivir for the treatment of COVID-19 and is waiving all benefits that accompany the designation. Gilead is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir, without the orphan drug designation. Recent engagement with regulatory agencies has demonstrated that submissions and review relating to remdesivir 

for the treatment of COVID-19 are being expedited. 

 

In early March, Gilead sought and was subsequently granted an orphan drug designation for the remdesivir 

as a potential treatment for COVID-19. Orphan drug designation is granted by the FDA in situations where 

the disease affects fewer than 200,000 patients in the United States. Among the benefits of orphan drug designation, this status results in a waiver of the requirement to provide a pediatric study plan prior to the submission of a New Drug Application – a process that can to take up to 210 days to review.

 

Gilead recognizes the urgent public health needs posed by the COVID-19 pandemic. The company is working to advance the development of remdesivir as quickly as possible, and will provide updates as they become available.

 

中文鏈接：

https://mp.weixin.qq.com/s/fYOLl72Js-yi7MDAgIU0LA

英文報道：

https://www.npr.org/sections/health-shots/2020/03/25/821534016/drugmaker-asks-fda-to-rescind-rare-disease-status-perks-for-covid-19-drug

 

 

所有跟帖： 

• 應該放棄。我在想，Gilead和FDA難道在三月還以為全美的COVID－19確診病例會小於20萬？ -虎嗅薔薇- ♀ (0 bytes) () 03/26/2020 postreply 07:37:50

• 馬上就到了 -吃與活- ♂ (0 bytes) () 03/26/2020 postreply 08:06:18

• 這是什麽意思？有效果為什麽不上市 -greenlane- ♀ (0 bytes) () 03/26/2020 postreply 07:55:21

• 這種給稀有病藥的資格要求病人在二十萬以下。我的理解：吉利德放棄這個資格，是尋求正常藥的批準，並不是放棄該藥的權利 -吃與活- ♂ (0 bytes) () 03/26/2020 postreply 08:09:45

• 而且，即使不具孤兒藥資格，隻要臨床試驗結果好，一樣會以快速通道批準的。 -虎嗅薔薇- ♀ (0 bytes) () 03/26/2020 postreply 08:19:42

• 英文看起來費事，看了鏈接的中文版，感動了。 -OceanSound- ♀ (0 bytes) () 03/26/2020 postreply 11:14:25

• 乙肝疫苗那個是已經完成的, 人民的希望不一定 -吃與活- ♂ (0 bytes) () 03/26/2020 postreply 11:41:23