Cerezyme supply shortage
The European Medicines Agency (EMEA) has been informed by Genzyme, the marketing authorization holder for Cerezyme (imiglucerase), that the supply shortage of the product is more significant than originally anticipated. The CHMP (Committee for Medicinal Products for Human Use) has therefore approved new temporary treatment recommendations to replace those proposed by the company in June 2009. According to these, only patients with the greatest treatment need will receive Cerezyme, albeit at a reduced dose, until the shortage is resolved.
Indications
Cerezyme is used in the treatment of patients with Gaucher disease, a rare inherited lipid storage disorder in which patients are deficient in the enzyme β-glucocerebrosidase.
Further information
The detailed, updated recommendations can be found on the EMEA website. These are temporary recommendations that do not change the currently approved product information for Cerezyme. It is expected that these changes will need to remain in use through the end of the year.
Queries:
Institute Science & Information
Dr. Milena Stain
Phone: +43 (0)50 555-36803
E-mail: milena.stain@ages.at
