Overview
Juvista has been investigated for the treatment, prevention, and basic science of Scars, Keloid, and Cicatrix.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
Avotermin (Juvista): A Comprehensive Analysis of a First-in-Class Anti-Scarring Biologic
Executive Summary
Avotermin, also known by the investigational brand name Juvista, is a recombinant human Transforming Growth Factor-beta 3 (TGF−β3) developed as a first-in-class, investigational biologic agent for the prophylactic improvement of cutaneous scarring.[1] It represented a pioneering therapeutic approach aimed at addressing a significant unmet medical need in dermatology, plastic surgery, and general surgery, fields where existing scar treatments often lack robust, evidence-based support from rigorously controlled clinical trials.[3] The development of Avotermin was founded on an elegant scientific rationale derived from the observation of scar-free wound healing in early-gestation fetuses, a phenomenon attributed to a local cytokine environment dominated by
TGF−β3.[5] The therapeutic strategy was to pharmacologically replicate this regenerative environment in adult wounds by administering exogenous
TGF−β3 at the time of surgical incision.
This rationale was strongly supported by an extensive and successful program of Phase I and II clinical trials. These studies, involving over 1,500 human subjects, consistently demonstrated that intradermal injections of Avotermin were well-tolerated and produced statistically significant improvements in scar appearance compared to placebo across a range of surgical settings.[7] These promising results generated considerable optimism and led to a major licensing agreement with Shire plc for development and commercialization outside of Europe.[8]
Clinical Trials
| Title | Posted | Study ID | Phase | Status | Sponsor | 
|---|---|---|---|---|---|
| 2009/12/09 | Phase 1 | Completed | Renovo | ||
| 2009/09/25 | Phase 2 | Completed | Renovo | ||
| 2009/09/25 | Phase 1 | Completed | Renovo | ||
| 2009/09/16 | Phase 1 | Completed | Renovo | ||
| 2009/09/16 | Phase 1 | Completed | Renovo | ||
| 2009/09/16 | Phase 1 | Completed | Renovo | ||
| 2009/02/19 | Phase 1 | Completed | Renovo | ||
| 2009/02/19 | Phase 1 | Completed | Renovo | ||
| 2009/02/04 | Phase 1 | Completed | Renovo | ||
| 2009/01/13 | Not Applicable | Withdrawn | Renovo | 
FDA Drug Approvals
| Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date | 
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
| Approved Product | Authorization Holder | Status | Issued Date | 
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
| Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date | 
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
| Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date | 
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
| Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date | 
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
| Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date | 
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
| Approved Product | Company | DIN | Dosage Form | Strength | Market Date | 
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
| Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status | 
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
| Approved Product | Company | License Number | Dosage Form | Strength | Approval Date | 
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
| Approved Product | Company | License Number | Dosage Form | Strength | Approval Date | 
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
| Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date | 
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
| Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date | 
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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