Drugs / Taliglucerase alfa
Taliglucerase alfa
Regulatory milestones approvals, filings & regulatory actions · 11 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed Gaucher ichthyosis restrictive dermopathy 7 milestones | |||||
| Filed | US (FDA) | ELELYSO | Gaucher ichthyosis restrictive dermopathy | 2014-01-13 | “An application for a pediatric indication of ELELYSO has been submitted to the U.S. Food and Drug Administration.” protalix.com ↗ |
| Refused (EMA) | EU (EMA) | Elelyso | Gaucher ichthyosis restrictive dermopathy | 2012-10-25 | “Commission Decision refusing the Marketing Authorization for taliglucerase alfa, an enzyme replacement therapy (ERT) for the treatment of Gaucher disease.” protalix.com ↗ authority europa.eu ↗ |
| Refused (EMA) | EU (EMA) | — | Gaucher ichthyosis restrictive dermopathy | 2012-06-22 | “CHMP has adopted an Opinion recommending against the Marketing Authorization of taliglucerase alfa, an enzyme replacement therapy (ERT) for the treatment of Gaucher disease.” protalix.com ↗ |
| Filed | US (FDA) | — | Gaucher ichthyosis restrictive dermopathy | 2011-08-17 | “Regulatory applications have been submitted for taliglucerase alfa in the United States, the European Union, Brazil and Israel.” protalix.com ↗ “FDA has accepted for review the resubmission of the taliglucerase alfa New Drug Application (NDA)” protalix.com ↗ |
| Rejected (CRL) | US (FDA) | — | Gaucher ichthyosis restrictive dermopathy | 2011-02-25 | “the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the Company's New Drug Application (NDA) for taliglucerase alfa” protalix.com ↗ “resubmission of the taliglucerase alfa New Drug Application (NDA) following the Company's receipt of a Complete Response Letter (CRL) in February 2011.” protalix.com ↗ |
| Filed | Other | — | Gaucher ichthyosis restrictive dermopathy | — | “To date, marketing applications for taliglucerase alfa have been submitted in the United States, European Union, Brazil, Israel and Australia.” protalix.com ↗ “Regulatory applications have been submitted for taliglucerase alfa in the United States, the European Union, Brazil and Israel.” protalix.com ↗ |
| Filed | EU (EMA) | — | Gaucher ichthyosis restrictive dermopathy | — | “Regulatory applications have been submitted for taliglucerase alfa in the United States, the European Union, Brazil and Israel.” protalix.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Label expansions (3) | US (FDA) | ELELYSO | — | 2014-08-27 – 2016-12-20 | fda.gov ↗ |
| Approved | US (FDA) | ELELYSO | — | 2012-05-01 | fda.gov ↗ |
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01747980 | Mar 2013 → Jan 2014 | Gaucher disease | Protalix | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT02107846 | Apr 2014 → Dec 2015 | Gaucher disease | Protalix | Completed | No outcome recorded |
| Phase 35 trials · 1 met primary | ||||||
| Phase 3 | NCT01411228 | Sep 2011 → Jul 2014 | Gaucher disease | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01422187 | Aug 2011 → May 2014 | Gaucher disease | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00712348 | Dec 2008 → Apr 2013 | Gaucher disease | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00705939 | Jun 2008 → May 2012 | Gaucher disease | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00376168 | Aug 2007 → Sep 2009 | Gaucher disease | Pfizer | Completed | Met primary |
| Phase 43 trials | ||||||
| Phase 4 | NCT04002830 | Nov 2020 → Jul 2023 | Gaucher disease type III | Ari Zimran | Completed | No outcome recorded |
| Phase 4 | NCT03021941 | Jul 2019 → Jun 2020 | Gaucher disease type I | Pfizer | Withdrawn | No outcome recorded |
| Phase 4 | NCT01132690 | Aug 2010 → May 2012 | Gaucher disease | Pfizer | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT04353466 | Jan 2017 → Jul 2021 | Gaucher disease type I | Shaare Zedek Medical Center | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT00962260 | — | Gaucher disease | Pfizer | No longer available | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2/3 | NCT05815004 Comparator | Oct 2023 → Dec 2027 | Gaucher disease type III | AVROBIO | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 32
| Date | Issuer | Release |
|---|---|---|
| 2017-06-01 | Protalix | Regulatory Protalix BioTherapeutics Announces FDA Approval to Operate its Current Facility as a Multi-Product Facility protalix.com ↗
Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today that a Supplemental New Drug Application (sNDA) submitted to the U.S. Food and Drug Administration (FDA) has been approved by the FDA. |
| 2015-02-12 | Pfizer | Results Safety and Efficacy of ELELYSO® (taliglucerase alfa) for Injection in Pediatric Patients with Type 1 Gaucher Disease in Long-term Outcome Study Presented at the WORLDSymposium 2015 pfizer.com ↗
At the end of the study, treatment-naïve patients treated with ELELYSO for 36 months demonstrated clinical improvements, as measured by a decrease in spleen and liver volume and an increase in platelet count. |
| 2014-06-27 | Protalix | Results Protalix Announces New Data on ELELYSO(TM) (taliglucerase alfa) Presented at the European Working Group on Gaucher Disease 2014 11th Meeting protalix.com ↗
These findings also reinforce that ELELYSO is an attractive alternative treatment for patients previously treated with imiglucerase. |
| 2014-05-30 | Protalix | Regulatory Protalix Announces ELELYSO(TM) (taliglucerase alfa) Approved in Canada for the Treatment of Gaucher Disease in Both Adult and Pediatric Patients protalix.com ↗
Health Canada has granted regulatory approval to ELELYSO™ (taliglucerase alfa for injection) for the long-term enzyme replacement therapy for both adult and pediatric patients with a confirmed diagnosis of Type 1 Gaucher disease. |
| 2014-05-22 | Protalix | Regulatory Protalix Announces ELELYSO(TM) (taliglucerase alfa) Approved in Australia for the Treatment of Gaucher Disease in Both Adult and Pediatric Patients protalix.com ↗
With this TGA decision, the drug is now licensed in ten countries and further regulatory filings are underway. |
| 2013-10-14 | Protalix | Results Protalix BioTherapeutics Announces Positive Phase I Clinical Trial Results for Oral GCD in Gaucher Disease Patients protalix.com ↗
Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today initial positive results from its phase I clinical trial of oral glucocerebrosidase (GCD), or Oral GCD (PRX-112), in patients with Gaucher disease. |
| 2013-04-29 | Protalix | Regulatory UPLYSO(TM) (alfataliglicerase) Approved in Mexico and Chile for the Treatment of Gaucher Disease protalix.com ↗
Protalix BioTherapeutics, Inc. (NYSE-MKT:PLX) (TASE:PLX), announced today that the Mexican Federal Commission for the Protection against Sanitary Risk (COFEPRIS) and the Public Health Institute of Chile have both granted regulatory approval to UPLYSO™ (alfataliglicerase) for the long-term enzyme replacement therapy for adults with a confirmed diagnosis of Type I Gaucher disease. |
| 2013-03-18 | Protalix | Regulatory UPLYSO(TM) (alfataliglicerase) Approved in Brazil by ANVISA for the Treatment of Gaucher Disease protalix.com ↗
Pfizer Inc. (NYSE:PFE) and Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX) announced today that the Brazilian National Health Surveillance Agency (ANVISA, Agencia Nacional de Vigilancia Sanitaria) has granted regulatory approval to UPLYSO™ (alfataliglicerase) for the long-term enzyme replacement therapy for adults with a confirmed diagnosis of Type I Gaucher disease. |
| 2013-03-07 | Protalix | Regulatory Protalix BioTherapeutics Receives Approval to Initiate Phase I Study in Gaucher Patients With PRX-112, an Orally-Administered Candidate for the Treatment of Gaucher Disease protalix.com ↗
Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today that it has received approval from the Israeli Ministry of Health to initiate a phase I clinical trial of PRX-112, or Oral GCD, the Company's orally-administered product candidate for the treatment of Gaucher disease. |
| 2012-11-01 | Protalix | Regulatory European Commission Issues Decision on Taliglucerase Alfa Marketing Authorization Application protalix.com ↗
The EC has endorsed the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) recommendation not to issue a Marketing Authorization for taliglucerase alfa in the European Union. |
| 2012-09-27 | Protalix | Regulatory Protalix BioTherapeutics Receives Marketing Authorization for Elelyso(TM) for the Treatment of Gaucher Disease From the Israeli Ministry of Health protalix.com ↗
Elelyso is the first plant cell-based biopharmaceutical approved for marketing by the Israeli Ministry of Health. |
| 2012-07-02 | Protalix | Results Protalix BioTherapeutics Announces New Clinical Data on taliglucerase alfa Presented at the 10th Annual European Working Group on Gaucher Disease Meeting protalix.com ↗
At 36 months, the patients treated with taliglucerase alfa demonstrated a significant improvement in fat fraction from baseline (p-value = 0.012 after 36 months of follow-up). |
| 2012-06-22 | Protalix | Regulatory EMA Adopts Opinion on Taliglucerase Alfa Marketing Authorization Application protalix.com ↗
Pfizer Inc. (NYSE:PFE) and Protalix BioTherapeutics, Inc. (NYSE-MKT:PLX) (TASE:PLX) today announced that the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) has adopted an Opinion recommending against the Marketing Authorization of taliglucerase alfa, an enzyme replacement therapy (ERT) for the treatment of Gaucher disease. |
| 2012-05-01 | Protalix | Regulatory Protalix BioTherapeutics to Review FDA Approval of ELELYSO(TM) protalix.com ↗
ELELYSO™ (taliglucerase alfa), was approved for marketing by the U.S. Food and Drug Administration on May 1, 2012 |
| 2012-05-01 | Protalix | Regulatory Pfizer And Protalix BioTherapeutics Announce FDA Approval Of ELELYSO(TM) (taliglucerase alfa) For The Treatment Of Gaucher Disease protalix.com ↗
Pfizer Inc.(NYSE:PFE) and Protalix BioTherapeutics, Inc. (NYSE-AMEX:PLX, TASE:PLX) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved ELELYSO(TM) (taliglucerase alfa) for injection, an enzyme replacement therapy (ERT) for the long-term treatment of adults with a confirmed diagnosis of type 1 Gaucher disease. |
| 2012-02-09 | Protalix | Results Protalix Announces New Clinical Data on Taliglucerase Alfa to be Presented at the WORLD Lysosomal Disease Network Symposium protalix.com ↗
Patients treated with taliglucerase alfa in the extension trial continued to demonstrate a statistically significant reduction in mean spleen volume after 24 months, compared with baseline, in both treatment groups. |
| 2011-12-06 | Protalix | Regulatory FDA Extends Taliglucerase Alfa PDUFA Date to May 1, 2012 protalix.com ↗ |
| 2011-09-08 | Protalix | Results Protalix BioTherapeutics' Taliglucerase Alfa Phase III Results Published in Blood, the Journal of the American Society of Hematology protalix.com ↗
Additionally, patients treated with taliglucerase alfa in the phase III clinical trial demonstrated an increase in hemoglobin, decrease in liver volume and increase in platelet count. |
| 2011-08-17 | Protalix | Regulatory Protalix BioTherapeutics Announces FDA Accepts for Review Complete Response Resubmission for Taliglucerase Alfa and Assigns PDUFA Date protalix.com ↗
Protalix BioTherapeutics, Inc. (NYSE-AMEX:PLX, TASE:PLX), announced today that the U.S. Food & Drug Administration (FDA) has accepted for review the resubmission of the taliglucerase alfa New Drug Application (NDA) following the Company's receipt of a Complete Response Letter (CRL) in February 2011. |
| 2011-08-01 | Protalix | Regulatory Protalix Submits Reply to FDA Complete Response Letter for Taliglucerase Alfa and Reports Top-Line Results from the Company's Switchover Trial protalix.com ↗
The Company's submission addresses the issues identified by the FDA in the Complete Response Letter, including the request for clinical data from the Company's switchover trial and long-term extension trial, and additional information relating to chemistry, manufacturing and controls (CMC). |
| 2011-02-25 | Protalix | Regulatory FDA Issues Complete Response Letter for Taliglucerase Alfa New Drug Application protalix.com ↗
Protalix BioTherapeutics, Inc. (NYSE Amex: PLX; TASE: PLX), announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the Company's New Drug Application (NDA) for taliglucerase alfa for the treatment of Gaucher disease. |
| 2011-02-18 | Protalix | Results Protalix to Present New Data on taliglucerase alfa and Preclinical Data on Oral Enzyme glucocerebrosidase at the WORLD Lysosomal Disease Network Symposium protalix.com ↗ |
| 2010-11-02 | Protalix | Results Protalix BioTherapeutics Announces Preliminary Top-Line Positive Data from taliglucerase alfa Switchover Trial protalix.com ↗
The data indicate that patients can safely be switched to taliglucerase alfa from imiglucerase (Cerezyme(R)). |
| 2010-07-13 | Protalix | Regulatory Protalix BioTherapeutics Announces French ATU Granted for taliglucerase alfa for the Treatment of Gaucher Disease protalix.com ↗
Protalix BioTherapeutics, Inc. (NYSE-Amex: PLX) announced today that the French regulatory authority has granted an Autorisation Temporaire d'Utilisation (ATU), or Temporary Authorization for Use, for taliglucerase alfa for the treatment of Gaucher disease. |
| 2010-07-12 | Protalix | Regulatory Protalix BioTherapeutics Receives PDUFA Date for taliglucerase alfa protalix.com ↗ |
| 2010-02-02 | Protalix | Regulatory Protalix Announces NDA Submission Update for taliglucerase alfa for the Treatment of Gaucher Disease protalix.com ↗
Protalix BioTherapeutics, Inc. (NYSE Amex: PLX) announced today that, in connection with the New Drug Application (NDA) filed by the Company in December 2009 for taliglucerase alfa for the treatment of Gaucher disease, the U.S. Food and Drug Administration (FDA) has requested additional data regarding the Chemistry, Manufacturing and Controls (CMC) section of the NDA. |
| 2010-01-13 | Protalix | Regulatory European Medicines Agency's COMP Adopts Positive Opinion for the Orphan Drug Designation for Protalix's taliglucerase alfa protalix.com ↗ |
| 2009-10-15 | Protalix | Results Protalix BioTherapeutics Announces Positive Top-line Results from its Phase III Clinical Trial of UPLYSO™ for the Treatment of Gaucher Disease protalix.com ↗
Protalix BioTherapeutics, Inc. (NYSE-Amex: PLX), announced today positive top-line results from the Company's pivotal Phase III clinical trial of UPLYSO (taliglucerase alfa, previously referred to as prGCD) in treatment naive patients diagnosed with Gaucher disease. |
| 2009-09-08 | Protalix | Regulatory FDA Grants Protalix Orphan Drug Designation for prGCD protalix.com ↗
CARMIEL, Israel, September 8, 2009 (Business Wire) -- Protalix BioTherapeutics, Inc. (NYSE-Amex:PLX), announced today that it has received notice from the U.S. Food and Drug Administration (FDA) that the FDA's Office of Orphan Products Development has granted orphan drug designation to prGCD, the Company's proprietary plant cell expressed recombinant form of glucocerebrosidase (GCD) for the treatment of Gaucher disease. |
| 2009-08-25 | Protalix | Regulatory Protalix Receives FDA Fast Track Designation for prGCD protalix.com ↗
Protalix BioTherapeutics, Inc. (NYSE-Amex:PLX), announced today that it has eceived Fast Track Designation from the U.S. Food and Drug Administration (FDA) for prGCD, the Company's proprietary plant-cell expressed recombinant form of glucocerebrosidase (GCD) for the treatment of Gaucher disease. |
| 2009-08-17 | Protalix | Regulatory U.S. Food and Drug Administration Approves Protalix’s Treatment Protocol for prGCD protalix.com ↗
Protalix BioTherapeutics, Inc. (NYSE-Amex:PLX), announced today that the U.S. Food and Drug Administration (FDA) has approved the Company's treatment protocol for prGCD, the Company's proprietary plant-cell expressed recombinant form of glucocerebrosidase (GCD) for the treatment of Gaucher disease. |
| 2009-07-06 | Protalix | Regulatory Protalix Approached by the FDA to Consider Submitting a Treatment Protocol for the Use of prGCD in Patients with Gaucher Disease Allowing Expanded Access to prGCD protalix.com ↗
The FDA indicated to the Company that it believes the Company's development program for prGCD satisfies the regulatory criteria required to supply prGCD for expanded access to patients under a treatment protocol. |
All press releases naming this drug 50 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | taliglucerase alfa | “Taliglucerase alfa is a beta-glucocerebrosidase enzyme replacement therapy approved in the United States, Israel, and other countries for treatment of Type 1 Gaucher disease in...” PMID 26053270 ↗ Jun 20158“This is a multicenter study to assess the safety and efficacy of taliglucerase alfa (60 units/kg) in previously untreated subjects of any age with Type 3 GD.” NCT04002830 ↗ “Elelyso (taliglucerase alfa)” NCT03021941 ↗ “taliglucerase alfa” NCT05815004 ↗ |
| Known as | Elelyso | “Intravenous infusion of Taligluucerase alfa (Elelyso) in treatment-naive patients with type 3 Gaucher disease” NCT04002830 ↗ |
| Known as | Plant cell expressed recombinant glucocerebrosidase | “Plant cell expressed recombinant glucocerebrosidase (prGCD)” NCT00962260 ↗ |
| Known as | plant recombinant human glucocerebrosidase | “Administration of PRX-112, a plant recombinant human glucocerebrosidase (prGCD) using plant cells as carrier vehicle” NCT01747980 ↗ |
| Known as | prGCD | “Administration of PRX-112, a plant recombinant human glucocerebrosidase (prGCD) using plant cells as carrier vehicle” NCT01747980 ↗ |
| Known as | PRX-112 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01747980 ↗ |
| Action | Restore | “a novel enzyme replacement therapy for Gaucher disease” PMID 21900191 ↗ Sep 2011 |
| Modality | Protein / enzyme biologic | “Taliglucerase alfa is a beta-glucocerebrosidase enzyme replacement therapy approved in the United States, Israel, and other countries for treatment of Type 1 Gaucher disease in...” PMID 26053270 ↗ Jun 2015 |
| Route | Intravenous | “receive intravenous (IV) infusions of taliglucerase alfa every two weeks” NCT00712348 ↗ |