Supply shortage of Cerezyme more severe than expected
The supply shortage of Genzyme’s Cerezyme (imiglucerase), reported by the European Medicines Agency (EMEA) earlier this year (PJ Online, 10 July 2009), is more severe than previously thought
The supply shortage of Genzyme’s Cerezyme (imiglucerase), reported by the European Medicines Agency (EMEA) earlier this year, is more severe than previously thought.
The agency’s Committee for Medicinal Products for Human Use has agreed new temporary treatment recommendations: only patients at greatest need of treatment — infants, children and adolescents, and adults with severe, life-threatening progression of Gaucher’s disease — will receive Cerezyme, and then at a reduced dose, until the supply situation is resolved (see Panel below).
Genzyme is sending information to all Cerezyme prescribers on how to select patients for dose reduction, switch to alternative treatment or suspend treatment. The company has also said that the stock-sparing measures will have no impact on supplies to ongoing clinical trials.
The production site bioreactors have been cleaned and manufacture of both medicines has resumed. However, Genzyme has informed the EMEA that the existing stocks of Cerezyme are lower than previously reported.
The EMEA expects the temporary recommendations to continue until the end of 2009. The temporary treatment recommendations for Fabrazyme issued in June 2009 remain unchanged.
Updated recommendations during the supply shortage
Citation: The Pharmaceutical Journal URI: 10975871
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