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VPRIV Approval History

  • FDA approved: Yes (First approved February 26th, 2010)
  • Brand name: VPRIV
  • Generic name: velaglucerase alfa
  • Dosage form: for Injection
  • Company: Shire plc
  • Treatment for: Gaucher Disease

VPRIV (velaglucerase alfa) is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy for pediatric and adult patients with Type 1 Gaucher disease.

Development History and FDA Approval Process for VPRIV

Feb 26, 2010Approval FDA Approves VPRIV to Treat Gaucher Disease
Nov  4, 2009FDA Grants Priority Review for Shire's velaglucerase alfa for Type 1 Gaucher Disease
Sep  2, 2009Shire Completes Submission of NDA for Velaglucerase Alfa for Type 1 Gaucher Disease and Reports Positive Results for Remaining Two Phase III Trials
Jul  7, 2009Shire has Filed a Treatment Protocol for Velaglucerase Alfa for Gaucher Disease

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