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Elelyso Approval History

FDA Approved: Yes (First approved May 1, 2012)
Brand name: Elelyso
Generic name: taliglucerase alfa
Previous Name: Uplyso
Company: Protalix BioTherapeutics, Inc.
Treatment for: Gaucher Disease

Elelyso (taliglucerase alfa) is a plant-cell expressed recombinant form of glucocerebrosidase for the treatment of Gaucher disease.

Development History and FDA Approval Process for Elelyso

DateArticle
May  1, 2012Approval FDA Approves New Orphan Drug Elelyso to Treat a Form of Gaucher Disease
Dec 15, 2011FDA Extends Taliglucerase Alfa PDUFA Date to May 1, 2012
Aug 24, 2011Protalix BioTherapeutics Announces FDA Accepts for Review Complete Response Resubmission for Taliglucerase Alfa and Assigns PDUFA Date
Aug 17, 2011Protalix BioTherapeutics Announces FDA Accepts for Review Complete Response Resubmission for Taliglucerase Alfa and Assigns PDUFA Date
Aug  1, 2011Protalix Submits Reply to FDA Complete Response Letter for Taliglucerase Alfa and Reports Top-Line Results from the Company's Switchover Trial
Feb 25, 2011FDA Denies Taliglucerase Alfa New Drug Application
Jul 12, 2010Protalix BioTherapeutics Receives PDUFA Date for taliglucerase alfa
Feb  2, 2010Protalix Announces NDA Submission Update for taliglucerase alfa for the Treatment of Gaucher Disease
Dec 10, 2009Protalix Completes NDA Submission for taliglucerase alfa for the Treatment of Gaucher's Disease
Aug 17, 2009U.S. Food and Drug Administration Approves Protalix's Treatment Protocol for prGCD
Jul 14, 2009Protalix Holds Pre-NDA Meeting with FDA for prGCD

Further information

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