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.
美國食品藥品管理局批准了 Chiesi 集團 和 Protalix Biotherapeutics (納斯達克股票代碼:PLX)Elfabrio(pegunigalsidase alfa-iwxj)用於治療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.
該產品是一種酶替代療法,適用於患有罕見遺傳性疾病的成年人,在這種疾病中,脂肪物質會積聚異常沉積並導致疼痛,有時還會導致終末器官衰竭。
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 是一種聚乙二醇化酶替代療法。它是一種重組人類 α—半乳糖苷酶,一種在植物細胞培養中表達的酶,旨在提供較長的半衰期。
Also Read: Protalix Clocks 40% Decline In Q1 Revenues Reflecting Lower Sales To Brazil.
另請閱讀:Protalix預計第一季度收入下降40%,這反映了對巴西的銷售減少。
Just last week, the European Commission approved PRX-102 (pegunigalsidase alfa) in the European Union for Fabry disease.
就在上週,歐盟委員會批准了歐盟治療法布里病的 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 與之競爭 賽諾菲股份公司 (納斯達克股票代碼:SNY)Fabrazyme 和 Amicus Therapeutic (納斯達克股票代碼:FOLD)加拉福爾德在治療法布里病。
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.
差不多兩年前,兩家公司收到了美國食品藥品管理局的完整回覆信(CRL),內容涉及治療法布里病的pegunigalsidase alfa(PRX‐102)的上市申請。
Price Action: PLX shares are up 1.54% at $2.97 on the last check Wednesday.
價格走勢: 在週三的最後一張支票中,PLX股價上漲了1.54%,至2.97美元。
譯文內容由第三人軟體翻譯。
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