Drugs / Alipogene Tiparvovec
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Glybera | — | 2017-10-28 | europa.eu ↗ |
| Approved | EU (EMA) | Glybera | — | 2012-10-25 | europa.eu ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT02904772 | Oct 2016 → Jun 2020 | familial lipoprotein lipase deficiency | UniQure Biopharma B.V. | Withdrawn | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT00891306 | Feb 2009 → Aug 2010 | familial lipoprotein lipase deficiency | Amsterdam Molecular Therapeutics | Completed | No outcome recorded |
| Phase 2/3 | NCT01109498 | Aug 2007 → Jun 2013 | familial lipoprotein lipase deficiency | Amsterdam Molecular Therapeutics | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2017-04-20 | UniQure Biopharma B.V. | Regulatory uniQure Announces It Will Not Seek Marketing Authorization Renewal for Glybera in Europe gcs-web.com ↗
today announced that it will not pursue the renewal of the Glybera®(alipogene tiparvovec) marketing authorization in Europe when it is scheduled to expire on October 25, 2017. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2017-04-20 | UniQure Biopharma B.V. | uniQure Announces It Will Not Seek Marketing Authorization Renewal for Glybera in Europe gcs-web.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | alipogene tiparvovec | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02904772 ↗ |
| Known as | AAV1-LPL(S447X) | “alipogene tiparvovec (AAV1-LPLS447X) gene” PMID 22717743 ↗ Jun 20121“alipogene tiparvovec, AAV1-LPL(S447X)” PMID 22438229 ↗ Mar 2012 |
| Known as | Alipogen tiparvovec | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108304 ↗ |
| Known as | Glybera | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108304 ↗ |
| Action | Restore | “Alipogene tiparvovec corrects or restores lipoprotein lipase (LPL) function long term” NCT00891306 ↗ |
| Route | Intramuscular | “administered as a single set of intramuscular injections” NCT02904772 ↗ |
| Target | LPL | “Alipogene tiparvovec gene therapy ensures that a catabolically beneficial variant of the human LPL gene” NCT00891306 ↗ |