velaglucerase alfa
velaglucerase alfa: sourced relationships with 1 company · 1 clinical trial tracked · 1 FDA decision.
velaglucerase alfa evidence translation
What we can confirm
1 FDA record · 1 tracked trial
What it means
What to watch
Prepared research question
How could velaglucerase alfa → SHPGF affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence1 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Dated Pipeline Records (2)
| Company | Dated record stage |
|---|---|
| SHIRE PLC (SHPGF) Reported 2010-02-26 · Current development: unknownSource | Approved |
| SHIRE PLC (SHPGF) Reported 2010-02-26 · Current development: unknownSource | Approved |
Clinical Trial Registry Records (1)
A Multicenter, Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Velaglucerase Alfa in Chinese Subjects With Type 1 Gaucher Disease
Primary endpoint: Percentage of Participants With at Least One Serious Treatment-Emergent Adverse Event (TEAE)
FDA Decisions1 records
Frequently asked questions
Which companies have sourced relationships with velaglucerase alfa?
velaglucerase alfa has dated SEC/FDA relationship records for SHIRE PLC.
How many clinical trials involve velaglucerase alfa?
BioSniper tracks 1 clinical trial involving velaglucerase alfa.
What is velaglucerase alfa's latest FDA decision?
The most recent tracked FDA decision for velaglucerase alfa is Approval for 1 INDICATIONS AND USAGE VPRIV is indicated for long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease. VPRIV is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease. ( 1 ), dated February 26, 2010.