Shire announced that Vpriv (velaglucerase alfa for injection) has been FDA approved and made available for the treatment of Type 1 Gaucher disease. Vpriv is a hydrolytic lysosomal glucocerebroside-specific enzyme derived from a human cell line indicated for long-term enzyme replacement therapy in pediatric and adult patients with Type 1 Gaucher disease.
This approval was based on data from three Phase 3 clinical studies that enrolled a total of 99 patients ≥3 years old with Type 1 Gaucher disease that assessed the efficacy of Vpriv compared to imiglucerase. Studies 1 and 2 were conducted in patients not currently receiving Gaucher disease-specific therapy. Study 3 was conducted in patients who were receiving imiglucerase treatment immediately before starting Vpriv. Each study met its primary endpoint.
For more information call (800) 536-7878 or visit www.vpriv.com.