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agalsidase alfa (Replagal®)

 

Following a full submission

AWMSG advice

Status: Recommended

Agalsidase alfa (Replagal®) should be recommended for use within NHS Wales as a long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease. Patients receiving agalsidase alfa (Replagal®) will be entered into the Fabry Outcomes Survey. AWMSG urge the manufacturers of agalsidase alfa and agalsidase beta to develop a combined outcomes database. Treatment will be administered under the supervision of a physician experienced in the management of Fabry disease or other inherited metabolic diseases. Treatment will be administered according to agreed guidelines at appropriate designated centres. AWMSG will review this and other enzyme replacement therapies within three years.

 Final Recommendation: agalsidase alfa (Replagal) 11 (PDF, 215Kb)

Medicine details

Medicine name agalsidase alfa (Replagal®)
Formulation 1 mg/ml concentrate for solution for infusion
Reference number 11
Indication

Long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry Disease (α-galactosidase A deficiency)

Company Shire Human Genetic Therapies
BNF chapter Nutrition & blood
Assessment type Full
Status Recommended
Advice number 1107
NMG meeting date 12/09/2007
AWMSG meeting date 18/10/2007
Ratification by Welsh Government 15/11/2007
Date of issue 20/11/2007
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