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Glybera (ALIPOGENE TIPARVOVEC)
Glybera (generic name: ALIPOGENE TIPARVOVEC) is a Gene therapy drug developed by uniQure biopharma B.V.. It is currently FDA-approved (first approved 2012) for Familial lipoprotein lipase deficiency.
Glybera, also known as Alipogene Tiparvovec, is a gene therapy used to treat Lipoprotein Lipase Deficiency and related conditions such as Familial Hyperlipoproteinemia Type 1 and Familial Hyperchylomicronemia. It works by providing a functional copy of the triglyceride hydrolytic enzyme, which is deficient in these conditions, to help break down triglycerides.
At a glance
| Generic name | ALIPOGENE TIPARVOVEC |
|---|---|
| Sponsor | uniQure biopharma B.V. |
| Modality | Gene therapy |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2012 |
Approved indications
- Familial lipoprotein lipase deficiency
Common side effects
Key clinical trials
- Glybera Registry, Lipoprotein Lipase Deficient (LPLD) Patients
- Alipogene Tiparvovec for the Treatment of LPLD Patients (PHASE2)
- Duration of Effect of Alipogene Tiparvovec Treatment, Which Was Administered in Other Studies
- Safety and Efficacy in LPL-Deficient Subjects of AMT-011, an Adeno-Associated Viral Vector Expressing Human Lipoprotein Lipase [S447X] (PHASE2,PHASE3)
- Efficacy and Safety of Human Lipoprotein Lipase (LPL)[S447X] Expressed by an Adeno-Associated Viral Vector in LPL-deficient Subjects (PHASE2,PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Glybera CI brief — competitive landscape report
- Glybera updates RSS · CI watch RSS
- uniQure biopharma B.V. portfolio CI
Frequently asked questions about Glybera
What is Glybera?
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Who makes Glybera?
What is the generic name of Glybera?
When was Glybera approved?
What development phase is Glybera in?
Related
- Manufacturer: uniQure biopharma B.V. — full pipeline
- Therapeutic area: All drugs in Metabolic
- Indication: Drugs for Familial lipoprotein lipase deficiency
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing