因为之前那个许可只可以用到20万人以下的疾病,这个病过20万是肯定的了。 Gilead is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir, without the orphan drug designation," the company wrote in a statement. "Recent engagement with regulatory agencies has demonstrated that submissions and review relating to remdesivir for the treatment of COVID-19 are being expedited." To get orphan status, a drug company must show its drug serves a population of fewer than 200,000 people in the United States, "at the time of the submission of the request for orphan-drug designation." Gilead's latest statement indicates that this was early March.
Gilead 被以Sanders 为首的革命小将骂了个狗血淋头,钱总是有得赚,命没了就啥都嗝屁了... The company’s decision to seek orphan status for the drug had drawn immediate criticism. Senator Bernie Sanders of Vermont, who is seeking the Democratic presidential nomination, called it “truly outrageous,” noting that Gilead had received “tens of millions” of dollars from the federal government to develop the drug. https://www.google.com/amp/s/www.nytimes.com/2020/03/25/health/gilead-coronavirus-orphan-drug.amp.html
The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the treatment, prevention or diagnosis of a rare disease or condition, which is one that affects less than 200,000 persons in the US or meets cost recovery provisions of the act.Dec 20, 2018
Gilead is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir, without the orphan drug designation," the company wrote in a statement. "Recent engagement with regulatory agencies has demonstrated that submissions and review relating to remdesivir for the treatment of COVID-19 are being expedited."
To get orphan status, a drug company must show its drug serves a population of fewer than 200,000 people in the United States, "at the time of the submission of the request for orphan-drug designation." Gilead's latest statement indicates that this was early March. Cybercat 发表于 3/26/2020 10:58:17 AM
根据FDA网页上说明: The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the treatment, prevention or diagnosis of a rare disease or condition, which is one that affects less than 200,000 persons in the US or meets cost recovery provisions of the act. Orphan drug一般是给病人数量比较少,美国国内20万患者以下的疾病。所以药厂3月初申请orphan drug是无可厚非的,相当于申请一个快车道,所以FDA本周一批了也是照章办事,没有错误。之后有人抨击,药厂就在周三撤回了,就这么简单一件事。 目前这个药的几个trial,在clinicaltrials.gov都可以查到,同时有几个不同的trial在做。药厂有自信不走快车道,也一样可以尽快通过审批。
根据FDA网页上说明: The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the treatment, prevention or diagnosis of a rare disease or condition, which is one that affects less than 200,000 persons in the US or meets cost recovery provisions of the act.
The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the treatment, prevention or diagnosis of a rare disease or condition, which is one that affects less than 200,000 persons in the US or meets cost recovery provisions of the act.Dec 20, 2018 dilemma_mj 发表于 3/26/2020 11:36:56 AM
现在GILEAD have processed thousands of compassionate use requests and facilitated a smooth transition to our expanded access protocol. 后面expanded protocol 通过后更多的病人可以用药。
http://www.caixin.com/2020-03-26/101534156.html
【财新网】(记者 邸宁 实习记者 张阳)吉利德主动要求取消瑞德西韦孤儿药认定,这距离该药物获此认定仅仅3天。3月26日,美国制药企业吉利德发布声明称,已经向美国食品药品监督管理局(FDA)提出申请,要求收回授予瑞德西韦的孤儿药资格,并且放弃与孤儿药资格相关的所有优惠权益。
是不是放棄了优惠权益 of “孤儿药身份可以为制药公司提供在该是适应症上为期7年的市场独占期(exclusivity),即7年内任何药厂不得仿制该药物用于在获批适应症领域进行治疗。”
如果是的話,別的药厂就可以仿制了,Generic 即使是90%有效,也可能可以救更多的人吧。
Re,这个公司真的是非常高尚。以后买他家股票支持他。
根本不是,请看看英文报道。哪跟哪啊。
就是说这个公司放弃了批准以后独占市场7年的权利。
发现自己理解有误,删了。
没有呀。意识是他们有信心不用孤儿药,就按照普通药审批也能通过。孤儿药反而通不过,因为实际病人数超过标准了。按正常药通过也有专利保护期,只不过没有孤儿药的长。
不是存货不够啊,是因为用药手续太烦琐耗时较长,怕耽误病人病情。
另一个是Gilead说它现在产量跟不上,目前无法满足所有的需求,只能保证测试用药。
CEO医生出身果然不一样
据说它家3月初申请的,那个时候是符合要求的,FDA批也是符合条件才给批的
我看的是原本走orphan drug可以绕过儿童临床,新冠对儿童危险还是比对老年人小多了。所以当初他家申请orphan drug符合条件,FDA批了也符合条件。批完了被骂,他家就申请撤回,宁肯不要优惠。
不过现在也可以分开年龄段报审。重点是赶紧把药批了。
同情用药用了大概250 个case,已经暂时停止了,因为申请的太多,原话是"指数增长",investigational drug一般没有这么大规模的用法,药也没量产。现在只用于临床,除了美国,还有欧洲和日本。
那个层主说的是对的,拿到orphan drug status,就不需要在批准前先提交pediatric研究计划。
https://www.gilead.com/news-and-press/company-statements
看3/25那个statement
多谢层主和楼里牛人的讲解,看了半天都摸不着头脑,现在明白了
他家申请了独占市场的七年专利准备大赚一笔,被喷成shi了撤回了,也就是说别家可以做仿制药了 别觉得美国药厂有多高尚,都是有前科的
资本家算的清清楚楚呢,现在一个hiv的专利还在和政府打官司,同时hbv的药也在尝试争取改guideline让携带者就能开始用药。和政府搞好关系后面好处多多。当然眼下最重要的就是救人,这点确实很伟大
除非是首发?
很多英文报道,网上搜一下就是了。很多orphan drug可以免掉pediatric trial, 据说这个是它家3月初申请orphan drug的初衷。orphan drug原本是为了鼓励药厂开发病人数量少盈利少的药物,所以比普通申请多了不少优惠。做过有关orphan drug的工作,不会把orphan drug和儿童临床用药搞混的,谢谢。
胡说八道。它申请孤儿药是因为可以更快一点批准,现在美国covid的病人等着它救命,批准快一点对病人有利。非孤儿药也有5年专利保护期,孤儿药是7年。而不是像你说的不是孤儿药就能仿制了
现在主要是要快,盈利放在后边吧。不管什么初衷,只要能快点出来救人就很感激了
同意,好希望能大规模供药能赶紧跟上。目前虽然住院率不高,但这个病病程长,重症有延迟,眼看高峰就要来了,急人啊
orphan drug 不是做这个用的。。。那是对缺乏治疗手段的罕见病比如渐冻症的激励机制,因为患病人数太少研究成本太高,烧了好几个亿就为了那么几十个几千个病人,没有足够的incentive,big pharma是不会去做赔本生意的。 他家当年买了solvadi之后就把价钱从一年三万六涨到了八万四,这个可是当年Hep C唯一的cure,这回从国内征集可能药物的时候就开始造势宣传,揭盲有效的话本来就不会少赚,再要求orphan drug独占吃相就太难看了,你去看美国这边哪个明白人不骂的
五年是应该的,七年这个就过分了,这不风向不对他自己就撤回了? pediatric就是一个借口而已
我觉得明白人都支持他家的药快点上,眼下明白人考虑的首先是人命,不是算别人赚多少钱的问题
药厂的首要任务是救人,这点gilead做到了,远胜过某些只会骗钱还害人的中药厂商
对的。
“你们可以随便仿制了 我也不拿这个药赚钱了”
研发一个新药的投入成本是惊人的。。。
好!通俗易懂。
这真不是这么回事,Gilead 并没放弃专利权,只是按正常途径申请不走捷径了。
总算有个明白的。20万人以下患病才算orphan。眼看20万过了,会被取消的,还不如这时候自己要求取消,换个好名声。
为什么??
这个药就算正常定价并不比好多罕见病容易挣钱。因为每个病人总共就用5-10次药,罕见病好多药是每个病人天天年年用,一直用到死亡。
習大大能給來個指示,立馬就快了。
现实就是他来了个指示“加点中药”,然后搞黄了。