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velaglucerase alfa

Generic: velaglucerase alfa·Brand: Vpriv

velaglucerase alfa: developed by 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

Source-backed records connect velaglucerase alfa to SHPGF; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could velaglucerase alfa → SHPGF affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 1 study sponsors

Related indications

Gaucher Disease
Development Pipeline (2)
CompanyPhase
SHIRE PLC (SHPGF)Approved
SHIRE PLC (SHPGF)Approved
Clinical Trials (1)

A Multicenter, Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Velaglucerase Alfa in Chinese Subjects With Type 1 Gaucher Disease

NCT05529992·Phase 3·TKPHF
Completed

Primary endpoint: Percentage of Participants With at Least One Serious Treatment-Emergent Adverse Event (TEAE)

Interventionalopen20 enrolledStarted 2023-01Completion 2024-0810 sites · ChinaTakeda
FDA Decisions1 records
Approval1 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 )(SHPGF)FDA ↗
BLA022575Type 1 - New Molecular EntityOrphan DrugPriorityIntravenousPowder

Frequently asked questions

Who is developing velaglucerase alfa?

velaglucerase alfa is being developed by 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.