Fabry Disease Treatment Showdown: Protalix Bio's Elfabrio Joins the Ranks of Sanofi and Amicus Therapeutics
Fabry Disease Treatment Showdown: Protalix Bio's Elfabrio Joins the Ranks of Sanofi and Amicus Therapeutics
The FDA approved Chiesi Group and Protalix BioTherapeutics Inc's (NASDAQ:PLX) Elfabrio (pegunigalsidase alfa-iwxj) for treating adult patients with Fabry disease.
The product is an enzyme replacement therapy for adults with a rare, inherited disease in which abnormal deposits of fatty substances build up and cause pain and sometimes end-organ failure.
Elfabrio is a PEGylated enzyme replacement therapy. It is a recombinant human α–Galactosidase–A enzyme expressed in a plant-cell culture designed to provide a long half-life.
Also Read: Protalix Clocks 40% Decline In Q1 Revenues Reflecting Lower Sales To Brazil.
Just last week, the European Commission approved PRX-102 (pegunigalsidase alfa) in the European Union for Fabry disease.
Elfabrio competes with Sanofi SA's (NASDAQ:SNY) Fabrazyme and Amicus Therapeutics Inc's (NASDAQ:FOLD) Galafold in treating Fabry disease.
Almost two years back, the companies received a Complete Response Letter (CRL) from the FDA related to the marketing application of pegunigalsidase alfa (PRX‐102) for Fabry disease.
Price Action: PLX shares are up 1.54% at $2.97 on the last check Wednesday.
The FDA approved Chiesi Group and Protalix BioTherapeutics Inc's (NASDAQ:PLX) Elfabrio (pegunigalsidase alfa-iwxj) for treating adult patients with Fabry disease.
美国食品药品管理局批准了 Chiesi 集团 和 Protalix Biotherapeutics （纳斯达克股票代码：PLX）Elfabrio（pegunigalsidase alfa-iwxj）用于治疗法布里病的成年患者。
The product is an enzyme replacement therapy for adults with a rare, inherited disease in which abnormal deposits of fatty substances build up and cause pain and sometimes end-organ failure.
该产品是一种酶替代疗法，适用于患有罕见遗传性疾病的成年人，在这种疾病中，脂肪物质会积聚异常沉积并导致疼痛，有时还会导致终末器官衰竭。
Elfabrio is a PEGylated enzyme replacement therapy. It is a recombinant human α–Galactosidase–A enzyme expressed in a plant-cell culture designed to provide a long half-life.
Elfabrio 是一种聚乙二醇化酶替代疗法。它是一种重组人类 α—半乳糖苷酶，一种在植物细胞培养中表达的酶，旨在提供较长的半衰期。
Also Read: Protalix Clocks 40% Decline In Q1 Revenues Reflecting Lower Sales To Brazil.
另请阅读：Protalix预计第一季度收入下降40％，这反映了对巴西的销售减少。
Just last week, the European Commission approved PRX-102 (pegunigalsidase alfa) in the European Union for Fabry disease.
就在上周，欧盟委员会批准了欧盟治疗法布里病的 PRX-102（pegunigalsidase alfa）。
Elfabrio competes with Sanofi SA's (NASDAQ:SNY) Fabrazyme and Amicus Therapeutics Inc's (NASDAQ:FOLD) Galafold in treating Fabry disease.
Elfabrio 与之竞争 赛诺菲股份公司 （纳斯达克股票代码：SNY）Fabrazyme 和 Amicus Therapeutic （纳斯达克股票代码：FOLD）加拉福尔德在治疗法布里病。
Almost two years back, the companies received a Complete Response Letter (CRL) from the FDA related to the marketing application of pegunigalsidase alfa (PRX‐102) for Fabry disease.
差不多两年前，两家公司收到了美国食品药品管理局的完整回复信（CRL），内容涉及治疗法布里病的pegunigalsidase alfa（PRX‐102）的上市申请。
Price Action: PLX shares are up 1.54% at $2.97 on the last check Wednesday.
价格走势： 在周三的最后一张支票中，PLX股价上涨了1.54％，至2.97美元。
译文内容由第三方软件翻译。
风险及免责提示
- 分享到weixin
- 分享到qq
- 分享到facebook
- 分享到twitter
- 分享到微博
- 粘贴板
使用浏览器的分享功能，分享给你的好友吧