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FDA Approves Therapy to Treat Type 1 Gaucher Disease ROCKVILLE, Md -- March 1, 2010 -- The US Food and Drug Administration (FDA) has approved velaglucerase alfa for injection (VPRIV) to treat children and adults with Type 1 Gaucher disease. VPRIV provides long-term enzyme replacement therapy for Type 1 Gaucher disease. It is an alternative to imiglucerase (Cerezyme), which is currently in short supply. “The approval of VPRIV will provide a safe and effective alternative treatment for patients with Gaucher disease,” said Julie Beitz, MD, FDA’s Office of Drug Evaluation 3, Rockville, Maryland. “Patients who previously received [imiglucerase] as an enzyme replacement therapy for their Type 1 Gaucher disease can be safely switched to VPRIV.” The safety and effectiveness of VPRIV was assessed in 3 clinical studies involving 82 patients with Type 1 Gaucher disease aged 4 years and older. The studies included patients who switched to VPRIV after being treated with imiglucerase. The most common adverse reactions to VPRIV are allergic reactions. Other observed adverse reactions with VPRIV are headache, dizziness, abdominal pain, back pain, joint pain, nausea, fatigue/weakness, fever, and prolongation of activated partial thromboplastin time, a measure of clotting time. SOURCE: US Food and Drug Administration E-mail this page to a friend or colleague! To print, use this version