EMA panel advises Fabrazyme switch
pharmafile | July 7, 2010 | News story | Manufacturing and Production |Â Â Fabrazyme, Genzyme, manufacturing complianceÂ
Doctors in Europe have been told they should consider switching patients with Fabry disease away from treatment with Genzyme’s Fabrazyme because of the shortages in supply of the drug, according to the European Medicines Agency.
The official statement from the EMA’s Committee for Medicinal Products for Human Use (CHMP) is another boost for Shire’s rival product Replagal (agalsidase alfa), which has been making strong gains in Europe and has now claimed around 60% of the market.
In a statement, the CHMP said it has been obliged to revise its previous recommendations on the use of Fabrazyme (agalsidase beta) because the current supply of the drug “will not address the medical needs of the nearly 600 patients receiving Fabrazyme in Europe today”.
The shortages in Fabrazyme and other Genzyme products such as Cerezyme (imiglucerase) for Gaucher disease have resulted from quality defects in products made at its Allston Landing facility in the US. These include a viral contamination issue and the company is struggling to get its production back to capacity.
The CHMP issued temporary treatment recommendations in April to ensure that Fabrazyme continue to be available to European patients at greatest need of treatment.
In its latest revision, the panel indicates “that in situations where alternative treatment is available, no new patients should be started on Fabrazyme”.
“For patients receiving a dose of Fabrazyme less than 1 mg/kg every other week, physicians should consider switching to an alternative treatment, such as Replagal,” it continues. Those on doses of 1mg/kg or more should continue on Fabrazyme therapy.
In May, the CHMP asked Genzyme to carry out a risk assessment of its manufacturing processes and to prepare a detailed plan for improvement, as well as provide regular progress reports in the implementation of the plan.
Phil Taylor
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