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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