Drugs / lipegfilgrastim
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Lonquex | — | 2013-07-25 | europa.eu ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02306915 | Oct 2014 → Mar 2015 | — | Merckle GmbH | Completed | No outcome recorded |
| Phase 1 | NCT01585649 | Jul 2012 → Jun 2014 | sarcoma | Merckle GmbH | Completed | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT02044276 | Mar 2014 → Aug 2017 | aggressive B-cell non-Hodgkin lymphoma | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2013-08-08 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Receives European Marketing Authorization for Lonquex® (XM22 lipegfilgrastim) tevapharm.com ↗
Teva Pharmaceutical Industries Ltd (NYSE: TEVA) announced today that the European Commission has granted marketing authorization for Lonquex® (lipegfilgrastim). |
| 2013-06-03 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva’s Lonquex®(XM22 lipegfilgrastim) Recommended for Approval in the EU for the Reduction of Chemotherapy-Induced Neutropenia (CIN) tevapharm.com ↗
The CHMP positive opinion opens the way to a final approval decision from the European Commission expected within the next few months. |
| 2012-06-29 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces Progress of Biologic Investigational Drugs Evaluated to Treat Neutropenia in Breast Cancer Patients Undergoing Chemotherapy tevapharm.com ↗
In both phase III breast cancer studies the primary endpoint was achieved, demonstrating reduction in the duration of severe neutropenia (DSN) in cycle 1, comparable to pegfilgrastim results in both efficacy and safety measures. |
| 2011-06-06 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces Successful Results of Phase III Study of Its Long-Acting G-CSF Product (Lipegfilgrastim) in Breast Cancer Patients tevapharm.com ↗
We are pleased with the successful results of this Phase III study. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2013-08-08 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Receives European Marketing Authorization for Lonquex® (XM22 lipegfilgrastim) tevapharm.com ↗ |
| 2013-06-03 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva’s Lonquex®(XM22 lipegfilgrastim) Recommended for Approval in the EU for the Reduction of Chemotherapy-Induced Neutropenia (CIN) tevapharm.com ↗ |
| 2012-06-29 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Progress of Biologic Investigational Drugs Evaluated to Treat Neutropenia in Breast Cancer Patients Undergoing Chemotherapy tevapharm.com ↗ |
| 2011-06-06 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Successful Results of Phase III Study of Its Long-Acting G-CSF Product (Lipegfilgrastim) in Breast Cancer Patients tevapharm.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lipegfilgrastim | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01585649 ↗ |
| Known as | Lonquex | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594230 ↗ |
| Known as | XM-22 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594230 ↗ |
| Action | Activate | “Granulocyte colony stimulating factor receptor agonist” CHEMBL4594230 ↗ |
| Modality | Protein / enzyme biologic | — CHEMBL4594230 ↗ |
| Route | Subcutaneous | “subcutaneous (SC) injection of 6 mg lipegfilgrastim” NCT02044276 ↗ |
| Target | CSF3R | “Granulocyte colony stimulating factor receptor agonist” CHEMBL4594230 ↗ |